510(k) K972248 ยท CBK Ventilator, Continuous, Facility Use
NELLCOR PURITAN BENNETT GEMINI
| Applicant | Nellcor Puritan Bennett, Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Sep 12, 1997 |
| Received | Jun 16, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972248
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.