Clearance Summary
ANEROID SPHYGMOMANOMETER, DOCTOR TYPE received FDA 510(k) clearance under submission number K901506, sponsored by Yamasu Co. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1990-05-09.
- Submission: K901506
- Applicant / Sponsor: Yamasu Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1120
- Decision date: 1990-05-09
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.