K943110 is an FDA 510(k) clearance for the GAS SAMPLING INTERFACES. This device is classified as a Tubing, Pressure And Accessories (Class I - General Controls, product code BYX).
Submitted by Coast Medical, Inc. (Orange, US). The FDA issued a Cleared decision on August 19, 1994, 51 days after receiving the submission on June 29, 1994.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5860.
| 510(k) Number | K943110 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 1994 |
| Decision Date | August 19, 1994 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BYX — Tubing, Pressure And Accessories |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5860 |