510(k) K012034 ยท BZD Ventilator, Non-Continuous (Respirator)
MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT
| Applicant | Sensor Medics Corp., Yorba Linda CA, US |
| Decision | Substantially Equivalent, Jul 24, 2001 |
| Received | Jun 29, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012034
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.