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FDA 510(k)

AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE

K-Number: K021340 · 2003-01-30

ApplicantExternal Counterpulsation Lab
Decision Date2003-01-30
Product CodeDRN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is External Counterpulsation Lab. It received FDA 510(k) clearance on 2003-01-30 under 510(k) number K021340. 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 AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE?

AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE is a medical device that received FDA 510(k) clearance on 2003-01-30. The listed applicant is External Counterpulsation Lab. The 510(k) number is K021340.

When did AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE receive FDA 510(k) clearance?

AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE received FDA 510(k) clearance on 2003-01-30, under 510(k) number K021340.

Who is the listed applicant for AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE?

The FDA 510(k) record lists External Counterpulsation Lab as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE?

The FDA product code for AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE 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.

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Other records listing External Counterpulsation Lab as applicant

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.

K012141AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE

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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