The following data is part of a premarket notification filed by Panasonic Co. Div. Matsu Elec. Corp. America with the FDA for Panasonic Blood Pressure Meter, Zh-852ap, Zh-858pp.
Device ID | K860634 |
510k Number | K860634 |
Device Name: | PANASONIC BLOOD PRESSURE METER, ZH-852AP, ZH-858PP |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | PANASONIC CO. DIV. MATSU ELEC. CORP. AMERICA 333 MEADOWLAND PKWY. Secaucus, NJ 07094 |
Contact | Robert J Heath |
Correspondent | Robert J Heath PANASONIC CO. DIV. MATSU ELEC. CORP. AMERICA 333 MEADOWLAND PKWY. Secaucus, NJ 07094 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-20 |
Decision Date | 1986-07-01 |