Clearance Summary
ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE received FDA 510(k) clearance under submission number K003415, sponsored by Wang & Li, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2001-01-03.
- Submission: K003415
- Applicant / Sponsor: Wang & Li, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1120
- Decision date: 2001-01-03
Classification & Regulation
This clearance is catalogued under FDA product code DXQ and 21 CFR 870.1120, within the Cardiovascular review panel as a Class II device.