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 En-212.
Device ID | K832076 |
510k Number | K832076 |
Device Name: | ELECTRONIC BLOOD PRESS. METER EN-212 |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | PANASONIC CO. DIV. MATSU ELEC. CORP. AMERICA 4221 Richmond Rd., N.W. Walker, MI 49534 |
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 | 1984-10-26 |