K924193 is an FDA 510(k) clearance for the TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685). 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 June 16, 1993, 300 days after receiving the submission on August 20, 1992.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5800.
| 510(k) Number | K924193 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - De Novo Granted (SEKD) |
| Date Received | August 20, 1992 |
| Decision Date | June 16, 1993 |
| Days to Decision | 300 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 |