SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS
FDA 510(k) clearance K072233 · decided 2007-10-05
Clearance details
- K-number
- K072233
- Device name
- SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS
- Applicant
- Leonhard Lang GmbH
- Decision
- Substantially Equivalent
- Date received
- 2007-08-10
- Decision date
- 2007-10-05
- Days to decision
- 56 days
- Clearance type
- Special
- 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 |
|---|---|---|
| SKINTACT Electrodes for Defibrillation, 10X REF DF20, Rx only, Manufactured by Leonhard La recall (Z-2233-2009) | Leonhard Lang Gmbh | 2009-09-24 |
| S&W Electrodes for Defibrillation, 10 Defibrillation Electrodes, Reorder #90101, S & W Hea recall (Z-2234-2009) | Leonhard Lang Gmbh | 2009-09-24 |