Avive Automated External Defibrillator (AED) System
FDA premarket approval P210015 · decided 2022-10-31
Approval details
- PMA number
- P210015
- Trade name
- Avive Automated External Defibrillator (AED) System
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- Avive Solutions, Inc.
- Date received
- 2021-04-06
- Decision date
- 2022-10-31
- Days to decision
- 573 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Brisbane, CA
- Statement
- Approval for the Avive Automated External Defibrillator.
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