Clearance Summary
EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING received FDA 510(k) clearance under submission number K130439, sponsored by Chongqing Psk Sci-Tech Development 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 2013-12-12.
- Submission: K130439
- Applicant / Sponsor: Chongqing Psk Sci-Tech Development Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5225
- Decision date: 2013-12-12
Classification & Regulation
This clearance is catalogued under FDA product code DRN and 21 CFR 870.5225, within the Cardiovascular review panel as a Class II device.