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FDA 510(k)

NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE

K-Number: K023016 · 2002-12-04

ApplicantNicore Equipment & Leasing, Inc.
Decision Date2002-12-04
Product CodeDRN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Nicore Equipment & Leasing, Inc.. It received FDA 510(k) clearance on 2002-12-04 under 510(k) number K023016. 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 NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE?

NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE is a medical device that received FDA 510(k) clearance on 2002-12-04. The listed applicant is Nicore Equipment & Leasing, Inc.. The 510(k) number is K023016.

When did NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE receive FDA 510(k) clearance?

NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE received FDA 510(k) clearance on 2002-12-04, under 510(k) number K023016.

Who is the listed applicant for NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE?

The FDA 510(k) record lists Nicore Equipment & Leasing, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE?

The FDA product code for NICORE MODEL NCP-1 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 Nicore Equipment & Leasing, Inc. 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.

K980937NICORE MODEL ESP -1

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

View on FDA Database →

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

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