Clearance Summary
MECA WRIST BLOOD PRESSURE METER, MODEL EW243 AND MODEL EW254 received FDA 510(k) clearance under submission number K991458, sponsored by Matsushita Electric Corp. of America. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2000-04-10.
- Submission: K991458
- Applicant / Sponsor: Matsushita Electric Corp. of America
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2000-04-10
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.