K983000 is an FDA 510(k) clearance for the CRICOTHYROTOMY TUBE. This device is classified as a Tube, Tracheostomy (w/wo Connector) (Class II - Special Controls, product code BTO).
Submitted by Polamedco, Inc. (Marina Del Rey, US). The FDA issued a Cleared decision on October 27, 1999, 426 days after receiving the submission on August 27, 1998.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5800.
| 510(k) Number | K983000 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 1998 |
| Decision Date | October 27, 1999 |
| Days to Decision | 426 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BTO — Tube, Tracheostomy (w/wo Connector) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5800 |