Clearance Summary
PANASONIC WRIST BLOOD PRESSURE METER received FDA 510(k) clearance under submission number K942422, sponsored by King & Spalding. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1995-02-15.
- Submission: K942422
- Applicant / Sponsor: King & Spalding
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 1995-02-15
Classification & Regulation
This clearance is catalogued under FDA product code DXN and 21 CFR 870.1130, within the Cardiovascular review panel as a Class II device.