Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING

K-Number: K130439 · 2013-12-12

ApplicantChongqing Psk Sci-Tech Development Co., Ltd.
Decision Date2013-12-12
Product CodeDRN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING is the device name listed in this FDA 510(k) record. The listed applicant is Chongqing Psk Sci-Tech Development Co., Ltd.. It received FDA 510(k) clearance on 2013-12-12 under 510(k) number K130439. The device is classified under product code DRN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING?

EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING is a medical device that received FDA 510(k) clearance on 2013-12-12. The listed applicant is Chongqing Psk Sci-Tech Development Co., Ltd.. The 510(k) number is K130439.

When did EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING receive FDA 510(k) clearance?

EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING received FDA 510(k) clearance on 2013-12-12, under 510(k) number K130439.

Who is the listed applicant for EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING?

The FDA 510(k) record lists Chongqing Psk Sci-Tech Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING?

The FDA product code for EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING is DRN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: DRN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250756Pression Wave PRO External Counter-Pulsation SystemPression, Inc.K202108External Counterpulsation System, SoulaireVamed Medical Instrument Co., Ltd.K191955Enhanced External Counter Pulsation Device Plus Omay-AOmay(Guangzhou)Med Technologies Co., Ltd.K190683External Counterpulsation SystemVamed Medical Instrument Co., Ltd.K173483Pure Flow External Counter-Pulsation DeviceXtreem Pulse, LLCK082134CIRCULATOR BOOTCirculator Boot Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑