510(k) K000206 ยท DRX Electrode, Electrocardiograph
PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200
| Applicant | Axelgaard Mfg. Co., Ltd., Fallbrook CA, US |
| Decision | Substantially Equivalent, Apr 13, 2000 |
| Received | Jan 21, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000206
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.