SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL
FDA 510(k) clearance K081371 · decided 2008-09-24
Clearance details
- K-number
- K081371
- Device name
- SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL
- Applicant
- Leonhard Lang GmbH
- Decision
- Substantially Equivalent
- Date received
- 2008-05-15
- Decision date
- 2008-09-24
- Days to decision
- 132 days
- Clearance type
- Traditional
- Product code
- MKJ
- Device class
- 3
- Regulation number
- 870.5310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Stillwater, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059 recall (Z-0802-2015) | Leonhard Lang Gmbh | 2014-12-19 |