The following data is part of a premarket notification filed by Vitalog Corp. with the FDA for Vitalog Hms-3000.
Device ID | K874198 |
510k Number | K874198 |
Device Name: | VITALOG HMS-3000 |
Classification | Oximeter |
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 | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-09 |
Decision Date | 1988-03-22 |