Clearance Summary
ANEROID SPHYGMANOMETER WITH STETHOSCOPE, MODEL HS-50A received FDA 510(k) clearance under submission number K051021, sponsored by Shanghai Lord International Trade Co., Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2005-06-20.
- Submission: K051021
- Applicant / Sponsor: Shanghai Lord International Trade Co., Ltd.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1120
- Decision date: 2005-06-20
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.