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FDA 510(k)

A-V IMPULSE SYSTEM MODEL 6060

K-Number: K953648 · 1996-02-12

ApplicantNovamedix , Ltd.
Decision Date1996-02-12
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

A-V IMPULSE SYSTEM MODEL 6060 is the device name listed in this FDA 510(k) record. The listed applicant is Novamedix , Ltd.. It received FDA 510(k) clearance on 1996-02-12 under 510(k) number K953648. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A-V IMPULSE SYSTEM MODEL 6060?

A-V IMPULSE SYSTEM MODEL 6060 is a medical device that received FDA 510(k) clearance on 1996-02-12. The listed applicant is Novamedix , Ltd.. The 510(k) number is K953648.

When did A-V IMPULSE SYSTEM MODEL 6060 receive FDA 510(k) clearance?

A-V IMPULSE SYSTEM MODEL 6060 received FDA 510(k) clearance on 1996-02-12, under 510(k) number K953648.

Who is the listed applicant for A-V IMPULSE SYSTEM MODEL 6060?

The FDA 510(k) record lists Novamedix , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A-V IMPULSE SYSTEM MODEL 6060?

The FDA product code for A-V IMPULSE SYSTEM MODEL 6060 is JOW.

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 Novamedix , Ltd. 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.

K951683A-V IMPULSE SYSTEM MODEL 6060K914461A-V IMPULSE SYSTEM

Related Devices (Code: JOW)

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.

K261807Sequential Circulator (SC-4004-DL, SC-4008-DL)Bio Compression Systems, Inc.K254217AerloomEvolym, LLCK253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile MedicalK253386DVT GarmentVistar Medical Supplies Co., Ltd.K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , 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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