WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST
FDA premarket approval P010030/S073 · decided 2016-06-14
Approval details
- PMA number
- P010030
- Supplement
- S073
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST
- Generic name
- Wearable automated external defibrillator
- Applicant
- Zoll Manufacturing Corporation
- Date received
- 2016-03-16
- Decision date
- 2016-06-14
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- Approval for modifications to current software (bug fixes, improvements, background noise detection feature).
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510(k) clearances by this applicant
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|---|---|---|
| ZOLL Arrhythmia Management Sysyem (K190939) | Zoll Manufacturing Corporation | 2019-12-19 |
| ZOLL ECG Analysis Software (K182093) | Zoll Manufacturing Corporation | 2019-01-28 |
| µCor Heart Failure and Arrhythmia Management System (K172510) | Zoll Manufacturing Corporation | 2018-05-11 |