510(k) K162503 ยท DSH Recorder, Magnetic Tape, Medical
Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software
| Applicant | Cardiac Insight, Inc., Kirkland WA, US |
| Decision | Substantially Equivalent, Mar 24, 2017 |
| Received | Sep 7, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162503
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.