ZOLL AED PLUS
FDA 510(k) clearance K033474 · decided 2004-05-21
Clearance details
- K-number
- K033474
- Device name
- ZOLL AED PLUS
- Applicant
- Zoll Medical Corp
- Decision
- Substantially Equivalent
- Date received
- 2003-11-03
- Decision date
- 2004-05-21
- Days to decision
- 200 days
- Clearance type
- Traditional
- Product code
- MKJ
- Device class
- 3
- Regulation number
- 870.5310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Chelsmford, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Zoll AED Plus Defibrillator recall (Z-1206-2009) | ZOLL Medical Corporation, World Wide Headquarters | 2009-04-01 |