The following data is part of a premarket notification filed by Panasonic Co. Div. Matsu Elec. Corp. America with the FDA for Noninvasive Blood Pressure Measure Sys.
Device ID | K841103 |
510k Number | K841103 |
Device Name: | NONINVASIVE BLOOD PRESSURE MEASURE SYS |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | PANASONIC CO. DIV. MATSU ELEC. CORP. AMERICA ONE PANASONIC WAY Secaucus, NJ 07094 |
Contact | Robert S Marin |
Correspondent | Robert S Marin PANASONIC CO. DIV. MATSU ELEC. CORP. AMERICA ONE PANASONIC WAY 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 | 1984-03-14 |
Decision Date | 1984-10-26 |