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FDA 510(k)

AVIAFIT

K-Number: K111720 · 2011-09-16

ApplicantFlowmedic , Ltd.
Decision Date2011-09-16
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AVIAFIT is the device name listed in this FDA 510(k) record. The listed applicant is Flowmedic , Ltd.. It received FDA 510(k) clearance on 2011-09-16 under 510(k) number K111720. 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 AVIAFIT?

AVIAFIT is a medical device that received FDA 510(k) clearance on 2011-09-16. The listed applicant is Flowmedic , Ltd.. The 510(k) number is K111720.

When did AVIAFIT receive FDA 510(k) clearance?

AVIAFIT received FDA 510(k) clearance on 2011-09-16, under 510(k) number K111720.

Who is the listed applicant for AVIAFIT?

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

What is the FDA product code for AVIAFIT?

The FDA product code for AVIAFIT 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 Flowmedic , 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.

K071744AVIAFIT PULSATING LEGBAND

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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