The following data is part of a premarket notification filed by A-vox Systems, Inc. with the FDA for Avoximeter 4000.
| Device ID | K951485 |
| 510k Number | K951485 |
| Device Name: | AVOXIMETER 4000 |
| Classification | Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-monoxide |
| 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 | JKS |
| CFR Regulation Number | 862.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-30 |
| Decision Date | 1995-11-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950813590 | K951485 | 000 |
| 08426950452614 | K951485 | 000 |
| 08426950452577 | K951485 | 000 |
| 08426950088684 | K951485 | 000 |
| 08426950490791 | K951485 | 000 |
| 10711234530054 | K951485 | 000 |
| 10711234160053 | K951485 | 000 |
| 10711234160046 | K951485 | 000 |
| 10711234160039 | K951485 | 000 |