510(k) K001775 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM
| Applicant | Zoe Medical, Inc., Topsfield MA, US |
| Decision | Substantially Equivalent, Jan 12, 2001 |
| Received | Jun 12, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001775
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.