K140097 is an FDA 510(k) clearance for the AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM. This device is classified as a Device, Fixation, Tracheal Tube (Class I - General Controls, product code CBH).
Submitted by Applied Medical Technology, Inc. (Brecksville, US). The FDA issued a Cleared decision on September 24, 2014, 253 days after receiving the submission on January 14, 2014.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5770.
| 510(k) Number | K140097 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 14, 2014 |
| Decision Date | September 24, 2014 |
| Days to Decision | 253 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CBH — Device, Fixation, Tracheal Tube |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5770 |