K893919 is an FDA 510(k) clearance for the ANTEC AIRWAY SAMPLING DEVICE W/MOISTURE TRAP. This device is classified as a Circuit, Breathing (w Connector, Adaptor, Y Piece) (Class I - General Controls, product code CAI).
Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on September 15, 1989, 108 days after receiving the submission on May 30, 1989.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5240.
| 510(k) Number | K893919 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 1989 |
| Decision Date | September 15, 1989 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CAI — Circuit, Breathing (w Connector, Adaptor, Y Piece) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5240 |