K921128 is an FDA 510(k) clearance for the ENDOTRACHEAL TUBE STYLET. This device is classified as a Stylet, Tracheal Tube (Class I - General Controls, product code BSR).
Submitted by Eastmed Enterprises, Inc. (Marlton, US). The FDA issued a Cleared decision on June 2, 1992, 84 days after receiving the submission on March 10, 1992.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5790.
| 510(k) Number | K921128 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 1992 |
| Decision Date | June 02, 1992 |
| Days to Decision | 84 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 |