K050785 is an FDA 510(k) clearance for the AMSINO ENDOTRACHEAL TUBE. This device is classified as a Tube, Tracheal (w/wo Connector) (Class II - Special Controls, product code BTR).
Submitted by Amsino International, Inc. (Pomona, US). The FDA issued a Cleared decision on July 15, 2005, 109 days after receiving the submission on March 28, 2005.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5730.
| 510(k) Number | K050785 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 2005 |
| Decision Date | July 15, 2005 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BTR — Tube, Tracheal (w/wo Connector) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5730 |