The following data is part of a premarket notification filed by Vitalog Corp. with the FDA for Vitalog Pms-8.
| Device ID | K845051 |
| 510k Number | K845051 |
| Device Name: | VITALOG PMS-8 |
| Classification | Oximeter, Ear |
| Applicant | VITALOG CORP. 2484 OLD MIDDLEFIELD WAY Mountain View, CA 94043 |
| Contact | Bruce Rule |
| Correspondent | Bruce Rule VITALOG CORP. 2484 OLD MIDDLEFIELD WAY Mountain View, CA 94043 |
| Product Code | DPZ |
| CFR Regulation Number | 870.2710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-19 |
| Decision Date | 1985-05-15 |