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FDA 510(k)

EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP

K-Number: K030587 · 2003-05-30

ApplicantS-Tct Health, Inc.
Decision Date2003-05-30
Product CodeDRN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP is the device name listed in this FDA 510(k) record. The listed applicant is S-Tct Health, Inc.. It received FDA 510(k) clearance on 2003-05-30 under 510(k) number K030587. 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 (ECP) MODEL US-ECP?

EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP is a medical device that received FDA 510(k) clearance on 2003-05-30. The listed applicant is S-Tct Health, Inc.. The 510(k) number is K030587.

When did EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP receive FDA 510(k) clearance?

EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP received FDA 510(k) clearance on 2003-05-30, under 510(k) number K030587.

Who is the listed applicant for EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP?

The FDA 510(k) record lists S-Tct Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP?

The FDA product code for EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP is DRN.

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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, LLCK130439EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORINGChongqing Psk Sci-Tech Development Co., Ltd.

Official Source

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

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