The following data is part of a premarket notification filed by Xomed-treace, Inc. with the FDA for Xomed-treace Emg Endotracheal Tubeen.
| Device ID | K925640 |
| 510k Number | K925640 |
| Device Name: | XOMED-TREACE EMG ENDOTRACHEAL TUBEEN |
| Classification | Stimulator, Nerve |
| Applicant | XOMED-TREACE, INC. 6743 SOUTHPOINT DRIVE NORTH Jacksonville, FL 32216 -0980 |
| Contact | Terry C Mcmahon |
| Correspondent | Terry C Mcmahon XOMED-TREACE, INC. 6743 SOUTHPOINT DRIVE NORTH Jacksonville, FL 32216 -0980 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-09 |
| Decision Date | 1993-08-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169789548 | K925640 | 000 |
| 20643169358816 | K925640 | 000 |
| 20643169358809 | K925640 | 000 |
| 20643169358793 | K925640 | 000 |
| 20643169358786 | K925640 | 000 |
| 20885074446091 | K925640 | 000 |
| 20885074446060 | K925640 | 000 |
| 00763000745837 | K925640 | 000 |
| 00763000745820 | K925640 | 000 |
| 20643169358823 | K925640 | 000 |
| 20643169358830 | K925640 | 000 |
| 00643169789531 | K925640 | 000 |
| 00643169789524 | K925640 | 000 |
| 00643169358775 | K925640 | 000 |
| 00643169358768 | K925640 | 000 |
| 00643169358751 | K925640 | 000 |
| 00643169358737 | K925640 | 000 |
| 00643169358713 | K925640 | 000 |
| 00643169358690 | K925640 | 000 |
| 00763000745813 | K925640 | 000 |