FDA product code GZE
Implanted Diaphragmatic/Phrenic Nerve Stimulator
Neurology·Class 3·21 CFR 882.5830·Implantable
US regulatory classifications
- US Product Code (FDA)
- GZEView Product Code Classification →
- US Risk Class (FDA)
- Class 3
- US Regulation (CFR)
- 21 CFR 882.5830View CFR Regulation →
- Medical specialty
- Neurology
Device characteristics
- GMP exempt
- No
- Implantable
- Yes
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
Call for pmas to be filed by 7/7/86 per 51 fr 12101 on 4/8/86
Search keywords
Click to search for similar devices in our global database
About this record
Implanted Diaphragmatic/Phrenic Nerve Stimulator is a medical device type in the Neurology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.