K950713 is an FDA 510(k) clearance for the AIRGUIDE STYLETTE. This device is classified as a Stylet, Tracheal Tube (Class I - General Controls, product code BSR).
Submitted by Polamedco, Inc. (Inglewood, US). The FDA issued a Cleared decision on May 17, 1995, 91 days after receiving the submission on February 15, 1995.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5790.
| 510(k) Number | K950713 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 15, 1995 |
| Decision Date | May 17, 1995 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BSR — Stylet, Tracheal Tube |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5790 |