510(k) K853344 ยท CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)
4000 NON CONDUCTIVE ANESTHESIA VENTILATOR CIRCUIT
| Applicant | Sigma Medical, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 29, 1985 |
| Received | Aug 7, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853344
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.