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FDA 510(k)

NICORE MODEL ESP -1

K-Number: K980937 · 2000-09-15

ApplicantNicore Equipment & Leasing, Inc.
Decision Date2000-09-15
Product CodeDRN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NICORE MODEL ESP -1 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 2000-09-15 under 510(k) number K980937. 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 ESP -1?

NICORE MODEL ESP -1 is a medical device that received FDA 510(k) clearance on 2000-09-15. The listed applicant is Nicore Equipment & Leasing, Inc.. The 510(k) number is K980937.

When did NICORE MODEL ESP -1 receive FDA 510(k) clearance?

NICORE MODEL ESP -1 received FDA 510(k) clearance on 2000-09-15, under 510(k) number K980937.

Who is the listed applicant for NICORE MODEL ESP -1?

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 ESP -1?

The FDA product code for NICORE MODEL ESP -1 is DRN.

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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.

K023016NICORE MODEL NCP-1 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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