AED Pro Device
FDA premarket approval P160022/S012 · decided 2019-08-22
Approval details
- PMA number
- P160022
- Supplement
- S012
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AED Pro Device
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- ZOLL Medical Corporation
- Date received
- 2019-07-26
- Decision date
- 2019-08-22
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Chelsmford, MA
- Statement
- Addition of a conformal coating and hipot test to the analog board, and updates to the system level testing.
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| 731 Series Ventilator (K233486) | ZOLL Medical Corporation | 2024-12-13 |
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| ZOLL X Series (K142915) | ZOLL Medical Corporation | 2014-12-03 |
| ZOLL X SERIES (K141774) | ZOLL Medical Corporation | 2014-11-19 |