510(k) K202464 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Vital Sign Monitoring Sensor (Model :XK300)
| Applicant | Xandar Kardian, Inc., Seoul, KR |
| Decision | Substantially Equivalent, Apr 26, 2021 |
| Received | Aug 27, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202464
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.