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 |