The following data is part of a premarket notification filed by American Medical Products, Inc. with the FDA for Amp Portable Patient Pressure Monitor.
Device ID | K802600 |
510k Number | K802600 |
Device Name: | AMP PORTABLE PATIENT PRESSURE MONITOR |
Classification | Computer, Blood-pressure |
Applicant | AMERICAN MEDICAL PRODUCTS, 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 | 1980-10-21 |
Decision Date | 1980-11-12 |