The following data is part of a premarket notification filed by Sentinel with the FDA for Artrac Vital Signs Mon. Models 7000 And 5000 & Acc.
| Device ID | K904088 |
| 510k Number | K904088 |
| Device Name: | ARTRAC VITAL SIGNS MON. MODELS 7000 AND 5000 & ACC |
| Classification | Oximeter |
| Applicant | SENTINEL 6530 CORPORATE DR. Indianapolis, IN 46278 |
| Contact | Wm. R Fletcher |
| Correspondent | Wm. R Fletcher SENTINEL 6530 CORPORATE DR. Indianapolis, IN 46278 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-05 |
| Decision Date | 1991-02-05 |