The following data is part of a premarket notification filed by North American Philips Corp. with the FDA for Norelco Aneroid Blood Pressure Meter.
Device ID | K811634 |
510k Number | K811634 |
Device Name: | NORELCO ANEROID BLOOD PRESSURE METER |
Classification | Blood Pressure Cuff |
Applicant | NORTH AMERICAN PHILIPS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DXQ |
CFR Regulation Number | 870.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-06-10 |
Decision Date | 1981-06-30 |