510(k) K851529 ยท CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)
4010 NON CONDUCTIVE VENTILATOR CIRCUIT W/BACTERIAL
| Applicant | Sigma Medical, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 25, 1985 |
| Received | Apr 16, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K851529
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.