The following data is part of a premarket notification filed by Vitalog Corp. with the FDA for Vitalog Pms-8 (modification).
| Device ID | K871813 |
| 510k Number | K871813 |
| Device Name: | VITALOG PMS-8 (MODIFICATION) |
| Classification | Monitor, Breathing Frequency |
| Applicant | VITALOG CORP. 643 BAIR ISLAND RD. SUITE 300 Redwood, CA 94063 |
| Contact | Bruce Rule |
| Correspondent | Bruce Rule VITALOG CORP. 643 BAIR ISLAND RD. SUITE 300 Redwood, CA 94063 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-08 |
| Decision Date | 1987-11-23 |