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FDA 510(k)

MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V

K-Number: K033657 · 2003-12-19

ApplicantLiving Data Technologies Corporation
Decision Date2003-12-19
Product CodeDRN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V is the device name listed in this FDA 510(k) record. The listed applicant is Living Data Technologies Corporation. It received FDA 510(k) clearance on 2003-12-19 under 510(k) number K033657. 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 MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V?

MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V is a medical device that received FDA 510(k) clearance on 2003-12-19. The listed applicant is Living Data Technologies Corporation. The 510(k) number is K033657.

When did MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V receive FDA 510(k) clearance?

MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V received FDA 510(k) clearance on 2003-12-19, under 510(k) number K033657.

Who is the listed applicant for MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V?

The FDA 510(k) record lists Living Data Technologies Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V?

The FDA product code for MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V is DRN.

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Other records listing Living Data Technologies Corporation 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.

K023701ANGIONEW-IV

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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