510(k) K100310 ยท MWJ Electrocardiograph, Ambulatory (Without Analysis)
BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS
| Applicant | BTL Industries, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Oct 13, 2010 |
| Received | Feb 3, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100310
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.