230357
Radiofrequency Therapy Systems, Tissue Ablation, Cardiac
射频治疗系统、组织消融、心脏
Farapulse, Inc.·III·Hong Kong MDACS·Registered October 09, 2023
Device overview
- Risk class
- III
- Product code
- 18608
- State
- current
- Status
- N/A
- Product code detail
- 18608 Radiofrequency Therapy Systems, Tissue Ablation, Cardiac
Manufacturer (製造商)
- Name
- Farapulse, Inc.Farapulse, Inc.
- Address
- 3715 Haven Ave, Suite 110, Menlo Park, CA 94025 UNITED STATES3715 Haven Ave, Suite 110, Menlo Park, CA 94025 美国
Authorised representative (AR)
- Phone
- 29607100
Regulatory timeline
- Registration date
- October 09, 2023
- Expiry date
- October 09, 2028
Product models
FARASTAR Pulsed Field Ablation Generator (61M401), FARASTAR Recording System Module (RSM) (61M407), Cable Components to Generator and RSM (61M404, 61M405, 61M406, 61M408, 61M409, 61M410, 61M411, 61M412, 61M413, 61M415, 61M416, 61M417)
FARASTAR 脉冲场烧蚀发生器 (61M401), FARASTAR 记录系统模块 (RSM) (61M407), 发电机和 RSM 的电缆组件 (61M404, 61M405, 61M406, 61M408, 61M409, 61M410, 61M411, 61M412, 61M413, 61M415, 61M416, 61M417)
About this record
This profile provides complete Hong Kong MDACS registration information for Radiofrequency Therapy Systems, Tissue Ablation, Cardiac. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: Radiofrequency Therapy Systems, Tissue Ablation, Cardiac
產品資訊： 射频治疗系统、组织消融、心脏