The following data is part of a premarket notification filed by King & Spalding with the FDA for Panasonic Wrist Blood Pressure Meter.
Device ID | K942422 |
510k Number | K942422 |
Device Name: | PANASONIC WRIST BLOOD PRESSURE METER |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | KING & SPALDING 1730 PENNSYLVANIA AVENUE, NW Washington, DC 20006 -4706 |
Contact | Edward Basile |
Correspondent | Edward Basile KING & SPALDING 1730 PENNSYLVANIA AVENUE, NW Washington, DC 20006 -4706 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-05-20 |
Decision Date | 1995-02-15 |