The following data is part of a premarket notification filed by Ergomed, Inc. with the FDA for Trakeez.
| Device ID | K941384 |
| 510k Number | K941384 |
| Device Name: | TRAKEEZ |
| Classification | Device, Fixation, Tracheal Tube |
| Applicant | ERGOMED, INC. 5426 BILLINGTON DR. San Antonio, TX 78230 |
| Contact | J.t. Bowlin |
| Correspondent | J.t. Bowlin ERGOMED, INC. 5426 BILLINGTON DR. San Antonio, TX 78230 |
| Product Code | CBH |
| CFR Regulation Number | 868.5770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-22 |
| Decision Date | 1994-04-19 |