510(k) K030795 ยท DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
LIFESYNE SYSTEMS
| Applicant | Gmp/Companies, Inc., Fort Lauderdale FL, US |
| Decision | Substantially Equivalent, Aug 5, 2003 |
| Received | Mar 12, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030795
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2008 | Lifesync Corporation LS-232 Large 12 LeadWear Single Pack - Disposable ECG Monitoring component intended for use as a radiofrequency signal transmitter and receiver of electrocardiograph physiological signals which are di Terminated |
DRG | None listed |
| Sep 16, 2008 | Lifesync Corporation LS-202 Large LeadWear Combo Pack - Disposable ECG Monitoring component intended for use as a radiofrequency signal transmitter and receiver of electrocardiograph physiological signals which are displa Terminated |
DRG | None listed |
| Feb 27, 2007 | GMP Companies/Lifesync Corporation LifeSync ECG System - Disposable leadwear, Ls-222, Ls-223 Terminated |
DRG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.