510(k) K071011 ยท MWJ Electrocardiograph, Ambulatory (Without Analysis)
MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER
| Applicant | Braemar, Inc., Eagan MN, US |
| Decision | Substantially Equivalent, Apr 27, 2007 |
| Received | Apr 10, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071011
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.