510(k) K002414 ยท LBI Unit, Neonatal Phototherapy
PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE
| Applicant | Fisher & Paykel Healthcare, Ltd., East Tamaki, Auckland, NZ |
| Decision | Substantially Equivalent, Sep 25, 2000 |
| Received | Aug 7, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002414
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.