510(k) K964543 ยท CBK Ventilator, Continuous, Facility Use
INFRASONICS ADULT VENTILATOR TRENDING OPTION
| Applicant | Nellcor Puritan Bennett, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Feb 14, 1997 |
| Received | Nov 13, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964543
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.