The following data is part of a premarket notification filed by Vitalog Corp. with the FDA for Vitalog Pms-8 Monitor.
| Device ID | K812739 |
| 510k Number | K812739 |
| Device Name: | VITALOG PMS-8 MONITOR |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | VITALOG CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-29 |
| Decision Date | 1981-12-29 |