The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Electronic Blood Pressure Unit.
Device ID | K761302 |
510k Number | K761302 |
Device Name: | ELECTRONIC BLOOD PRESSURE UNIT |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | MEDLINE INDUSTRIES, 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 | 1976-12-11 |
Decision Date | 1977-01-05 |