The following data is part of a premarket notification filed by Associated Mills, Inc. with the FDA for Bp800, 850 1000.
Device ID | K841095 |
510k Number | K841095 |
Device Name: | BP800, 850 1000 |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | ASSOCIATED MILLS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-03-13 |
Decision Date | 1984-08-24 |