The following data is part of a premarket notification filed by A-vox Systems, Inc. with the FDA for Avoximeter.
Device ID | K932954 |
510k Number | K932954 |
Device Name: | AVOXIMETER |
Classification | Computer, Diagnostic, Programmable |
Applicant | A-VOX SYSTEMS, INC. 15315 GREY FOX TERRACE San Antonio, TX 78255 |
Contact | Shepherd |
Correspondent | Shepherd A-VOX SYSTEMS, INC. 15315 GREY FOX TERRACE San Antonio, TX 78255 |
Product Code | DQK |
CFR Regulation Number | 870.1425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-17 |
Decision Date | 1993-12-27 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AVOXIMETER 78511479 3035479 Live/Registered |
ACCRIVA DIAGNOSTICS, INC. 2004-11-04 |