510(k) K024247 ยท DRX Electrode, Electrocardiograph
SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL
| Applicant | Leonhard Lang GmbH, Stillwater MN, US |
| Decision | Substantially Equivalent, Jan 16, 2003 |
| Received | Dec 23, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K024247
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2015 | Leonhard Lang Medizintechnik GmbH ECG Electrodes:
50007 Stablebase SBW55
50675 Stablebase SBW55-15
58051 Skintact W-60
50547 Stablebase SBT60
Only OUS:
50476 Skintact W-60HP E3 I
58046 Skintact T-60 I Patz K920
58688 Dahlhausen Terminated |
DRX | None listed |
| Mar 28, 2015 | Leonhard Lang Medizintechnik GmbH Skintact ECG Electrode FS-50, Catalog no. 58028 , & Stable Base ECG Electrode SBT-60, Catalog no. 50547.
To acquire and transmit the electrical signal at the body surface to a processor that prod Terminated |
DRX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.