510(k) K971968 ยท DSA Cable, Transducer And Electrode, Patient, (Including Connector)
SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97)
| Applicant | Remington Medical, Inc., Alpharetta GA, US |
| Decision | Substantially Equivalent, Jul 23, 1997 |
| Received | May 28, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971968
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 9, 2014 | Remington Medical Inc. FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down.
Electrical extension cable intended to transmit signal from, or power or excitation signal to patient connected electrodes. The Terminated |
DSA | None listed |
| Aug 13, 2010 | Remington Medical Inc. Disposable Surgical Cable, Product Code: FL-601-97 (100), Single use, Rx Only, Remington Medical, Inc., 6830 Meadowridge Court, Alpharetta, GA 30005
Usage: Temporary pacing of open hearts: used with Terminated |
DSA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.