K921077 is an FDA 510(k) clearance for the DISPOSABLE INTUBATION KITS. This device is classified as a Tube, Tracheal (w/wo Connector) (Class II - Special Controls, product code BTR).
Submitted by Coast Medical Corp. (Orange, US). The FDA issued a Cleared decision on August 25, 1992, 176 days after receiving the submission on March 2, 1992.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5730.
| 510(k) Number | K921077 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 1992 |
| Decision Date | August 25, 1992 |
| Days to Decision | 176 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BTR — Tube, Tracheal (w/wo Connector) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5730 |