PEDIATRIC MULTI-FUNCTION ELECTRODES
FDA 510(k) clearance K915159 · decided 1992-02-07
Clearance details
- K-number
- K915159
- Device name
- PEDIATRIC MULTI-FUNCTION ELECTRODES
- Applicant
- Zmi Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-11-14
- Decision date
- 1992-02-07
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- DRF
- Device class
- 2
- Regulation number
- 870.1220
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Woburn, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Zoll Pediatric Electrodes labeled: Pedi Padz Multi-Function Electrode part Number: 8900-20 recall (Z-1380-04) | Bio-Detek, Inc. | 2004-08-18 |