Clearance Summary
Disposable Pressure Transducer received FDA 510(k) clearance under submission number K152472, sponsored by Zhejiang Haisheng Medical Device 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 2016-10-31.
- Submission: K152472
- Applicant / Sponsor: Zhejiang Haisheng Medical Device Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2850
- Decision date: 2016-10-31
Classification & Regulation
This clearance is catalogued under FDA product code DRS and 21 CFR 870.2850, within the Cardiovascular review panel as a Class II device.