510(k) K012712 ยท MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
NORAV HOLTER SYSTEM, MODEL NH-300 V1.07
| Applicant | Norav Medical , Ltd., Plymouth MN, US |
| Decision | Substantially Equivalent, May 8, 2002 |
| Received | Aug 14, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012712
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.