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510(k) K130439

EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING by Chongqing Psk Sci-Tech Development Co., Ltd. — Product Code DRN

K130439 is an FDA 510(k) premarket notification submitted by Chongqing Psk Sci-Tech Development Co., Ltd. for the device "EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING". The FDA issued a decision of Substantially Equivalent on December 12, 2013. The device falls under product code DRN (Device, Counter-Pulsating, External), a Class II device regulated under 21 CFR 870.5225.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2013
Date Received
February 21, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Counter-Pulsating, External
Device Class
Class II
Regulation Number
870.5225
Review Panel
CV
Submission Type

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FDA data resources