K934462 is an FDA 510(k) clearance for the ADULT ANESTHESIA BREATHING CIRCUIT KITS. This device is classified as a Circuit, Breathing (w Connector, Adaptor, Y Piece) (Class I - General Controls, product code CAI).
Submitted by Zefon Medical Products (Ocala, US). The FDA issued a Cleared decision on March 1, 1994, 169 days after receiving the submission on September 13, 1993.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5240.
| 510(k) Number | K934462 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | September 13, 1993 |
| Decision Date | March 01, 1994 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CAI — Circuit, Breathing (w Connector, Adaptor, Y Piece) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5240 |