The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Monitor, Pressurveil.
Device ID | K790135 |
510k Number | K790135 |
Device Name: | MONITOR, PRESSURVEIL |
Classification | Computer, Blood-pressure |
Applicant | CONCEPT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DSK |
CFR Regulation Number | 870.1110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-01-22 |
Decision Date | 1979-02-13 |