Clearance Summary
ANEROID SPHYGMOMANOMETER, MODEL KT-A01 received FDA 510(k) clearance under submission number K081951, sponsored by Wenzhou Kindcare Import & Export 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 2008-08-15.
- Submission: K081951
- Applicant / Sponsor: Wenzhou Kindcare Import & Export Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1120
- Decision date: 2008-08-15
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.