The following data is part of a premarket notification filed by Medical Parameters, Inc. with the FDA for Blood Pressure Monitoring Kits,walrus.
Device ID | K830754 |
510k Number | K830754 |
Device Name: | BLOOD PRESSURE MONITORING KITS,WALRUS |
Classification | Injector And Syringe, Angiographic |
Applicant | MEDICAL PARAMETERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DXT |
CFR Regulation Number | 870.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-03-10 |
Decision Date | 1983-08-12 |