510(k) K110463 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS)
| Applicant | Norav Medical , Ltd., Mitzpe Aviv, IL |
| Decision | Substantially Equivalent, Nov 10, 2011 |
| Received | Feb 17, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K110463
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.