The following data is part of a premarket notification filed by North American Philips Corp. with the FDA for Aneroid Blood Pressure Cuff #hc1400.
Device ID | K830686 |
510k Number | K830686 |
Device Name: | ANEROID BLOOD PRESSURE CUFF #HC1400 |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | NORTH AMERICAN PHILIPS CORP. 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 | 1983-03-04 |
Decision Date | 1983-05-18 |