K952100 is an FDA 510(k) clearance for the RUSCH ENDOTRACHEAL TUBE STYLET. This device is classified as a Stylet, Tracheal Tube (Class I - General Controls, product code BSR).
Submitted by Rusch, Inc. (Jeffrey, US). The FDA issued a Cleared decision on August 8, 1995, 96 days after receiving the submission on May 4, 1995.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5790.
| 510(k) Number | K952100 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 1995 |
| Decision Date | August 08, 1995 |
| Days to Decision | 96 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BSR — Stylet, Tracheal Tube |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5790 |