Machine for measuring heart rate
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Amplivox Ltd·Registered Mar 18, 2024- Analysis ID
- 240000583/PCBB-HN
- Submission ID
- 000.00.19.H26-240302-0004
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Amplivox Ltd
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Amplivox Ltd
- Authorized Representative
- CÔNG TY TNHH VẠN NIÊN
- Intended Use
- - Otowave 202: Otowave 202 is designed for use by audiologists, general practitioners, hearing aid consultants, and pediatric health specialists. The device performs two types of measurements: the tympanometry measurement, which is used to measure the compliance of the eardrum and the middle ear at a fixed frequency across a range of air pressures; and the reflex measurement, which is used to measure the reflex of the stapedius muscle. Otowave measures the reflex on the same side and, if selected, the reflex measurement will be automatically performed after the tympanometry measurement. - Otowave 302: This device is designed for use by trained professionals, such as audiologists, otolaryngologists, doctors, general practitioners, hearing aid consultants, pediatric health specialists, and hearing health specialists with similar educational qualifications. It should not be used by untrained individuals. Otowave is used to gather information about the health and function of the middle ear and outer ear, as well as to assess hearing function during the reflex sound measurement process. Otowave 302 can be used for all ages and performs the following types of measurements: the tympanometry measurement, which is used to measure the compliance of the eardrum and middle ear at a fixed frequency across a range of air pressures; and the reflex measurement, which is used to measure the reflex of the stapedius muscle. Otowave measures the reflex on the same side and, if selected, the reflex measurement will be automatically performed after the tympanometry measurement. - Otowave 302+: This device is designed for use by trained professionals, such as audiologists, otolaryngologists, doctors, general practitioners, hearing aid consultants, pediatric health specialists, and hearing health specialists with similar educational qualifications. It should not be used by untrained individuals. Otowave is used to gather information about the health and function of the middle ear and outer ear, as well as to assess hearing function during the reflex sound measurement process. Otowave 302+ can be used for all ages and performs the following types of measurements: the tympanometry measurement, which is used to measure the compliance of the eardrum and middle ear at 226Hz and 1000Hz across a range of air pressures; and the reflex measurement, which is used to measure the reflex of the stapedius muscle. Otowave measures the reflex on the same side and, if selected, the reflex measurement will be automatically performed after the tympanometry measurement.
- Registration Date
- Mar 18, 2024
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Access comprehensive regulatory information for Machine for measuring heart rate in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240000583/PCBB-HN and manufactured by Amplivox Ltd. The authorized representative in Vietnam is CÔNG TY TNHH VẠN NIÊN.
This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including Interacoustics A/S, Denmark, Theo theo phụ lục, and 2 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.