Skintact, various other tradenames
FDA 510(k) clearance K142803 · decided 2014-12-02
Clearance details
- K-number
- K142803
- Device name
- Skintact, various other tradenames
- Applicant
- Leonhard Lang GmbH
- Decision
- Substantially Equivalent
- Date received
- 2014-09-29
- Decision date
- 2014-12-02
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- MKJ
- Device class
- 3
- Regulation number
- 870.5310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Innsbruck, AT
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Leonhard Lang GmbH
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. Product Usage: M recall (Z-3109-2017) | Leonhard Lang Medizintechnik GmbH | 2017-09-12 |
| Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for recall (Z-0004-2017) | Leonhard Lang Medizintechnik GmbH | 2016-10-14 |