The following data is part of a premarket notification filed by Applied Medical Technology, Inc. with the FDA for Amt Endotracheal Tube Bridle Retention System.
| Device ID | K140097 |
| 510k Number | K140097 |
| Device Name: | AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM |
| Classification | Device, Fixation, Tracheal Tube |
| Applicant | APPLIED MEDICAL TECHNOLOGY, INC. 8000 KATHERINE BOULEVARD Brecksville, OH 44141 |
| Contact | Joshua Meinke |
| Correspondent | Joshua Meinke APPLIED MEDICAL TECHNOLOGY, INC. 8000 KATHERINE BOULEVARD Brecksville, OH 44141 |
| Product Code | CBH |
| CFR Regulation Number | 868.5770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-14 |
| Decision Date | 2014-09-24 |