K923834 is an FDA 510(k) clearance for the TRACHEOSTOMY CARE SET WITH GLOVES. This device is classified as a Tube, Tracheostomy (w/wo Connector) (Class II - Special Controls, product code BTO).
Submitted by American Healthcare Corp. (South Plainfield, US). The FDA issued a Cleared decision on December 10, 1992, 132 days after receiving the submission on July 31, 1992.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5800.
| 510(k) Number | K923834 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | July 31, 1992 |
| Decision Date | December 10, 1992 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BTO — Tube, Tracheostomy (w/wo Connector) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5800 |