The following data is part of a premarket notification filed by Panasonic Co. Div. Matsu Elec. Corp. America with the FDA for Electronic Blood Press. Meter-zh-820p.
Device ID | K832075 |
510k Number | K832075 |
Device Name: | ELECTRONIC BLOOD PRESS. METER-ZH-820P |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | PANASONIC CO. DIV. MATSU ELEC. CORP. AMERICA NJ |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-06-28 |
Decision Date | 1983-08-12 |