The following data is part of a premarket notification filed by Zee Medical Products Co., Inc. with the FDA for Zee Sphygmomanometer.
Device ID | K823501 |
510k Number | K823501 |
Device Name: | ZEE SPHYGMOMANOMETER |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | ZEE MEDICAL PRODUCTS CO., 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 | 1982-11-24 |
Decision Date | 1983-01-21 |