EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING— 510(k) K130439

Name: FDA 510(k) clearance K130439
Creator: U.S. Food and Drug Administration
Published: 2013-12-12

Substantially Equivalent

Chongqing Psk Sci-Tech Development Co., Ltd.

FDA 510(k) clearance K130439 for EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING, Substantially Equivalent on 2013-12-12. Applicant: Chongqing Psk Sci-Tech Development Co., Ltd.. Device class: 2.

Clearance details

Applicant: Chongqing Psk Sci-Tech Development Co., Ltd.
Product code: Code DRN
Device class: Class 2
Regulation: 21 CFR 870.5225
Advisory panel: Cardiovascular
Date received: 2013-02-21
Decision date: 2013-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, Guangdong, CN

Download summary PDF View on FDA.gov ↗

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