The following data is part of a premarket notification filed by A-vox Systems, Inc. with the FDA for Avoximeter.
| Device ID | K922075 |
| 510k Number | K922075 |
| Device Name: | AVOXIMETER |
| Classification | Oximeter |
| Applicant | A-VOX SYSTEMS, INC. 15315 GREY FOX TERRACE San Antonio, TX 78255 |
| Contact | A. P Shepherd |
| Correspondent | A. P Shepherd A-VOX SYSTEMS, INC. 15315 GREY FOX TERRACE San Antonio, TX 78255 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-04 |
| Decision Date | 1992-11-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10711234530160 | K922075 | 000 |
| 10711234530146 | K922075 | 000 |
| 10711234530023 | K922075 | 000 |
| 10711234160022 | K922075 | 000 |
| 10711234160015 | K922075 | 000 |
| 10711234530153 | K922075 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() AVOXIMETER 78511479 3035479 Live/Registered |
ACCRIVA DIAGNOSTICS, INC. 2004-11-04 |