510(k) K862921 ยท FMT Warmer, Infant Radiant
MODEL 10200 PREMATURE INFANT INCUBATOR
| Applicant | Rotem Industries C/O Medsys, Inc., Rutherford NJ, US |
| Decision | Substantially Equivalent, Apr 1, 1987 |
| Received | Aug 1, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862921
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.