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FDA 510(k)

UNIVERSITY HEALTH CARE PROCESSED ALTERNATING LEG PRESSURE (UHC APL) SLEEVE DEVICE

K-Number: K080551 · 2008-05-28

ApplicantUniversity of Utah Hospitals and Clinics
Decision Date2008-05-28
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

UNIVERSITY HEALTH CARE PROCESSED ALTERNATING LEG PRESSURE (UHC APL) SLEEVE DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is University of Utah Hospitals and Clinics. It received FDA 510(k) clearance on 2008-05-28 under 510(k) number K080551. 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 UNIVERSITY HEALTH CARE PROCESSED ALTERNATING LEG PRESSURE (UHC APL) SLEEVE DEVICE?

UNIVERSITY HEALTH CARE PROCESSED ALTERNATING LEG PRESSURE (UHC APL) SLEEVE DEVICE is a medical device that received FDA 510(k) clearance on 2008-05-28. The listed applicant is University of Utah Hospitals and Clinics. The 510(k) number is K080551.

When did UNIVERSITY HEALTH CARE PROCESSED ALTERNATING LEG PRESSURE (UHC APL) SLEEVE DEVICE receive FDA 510(k) clearance?

UNIVERSITY HEALTH CARE PROCESSED ALTERNATING LEG PRESSURE (UHC APL) SLEEVE DEVICE received FDA 510(k) clearance on 2008-05-28, under 510(k) number K080551.

Who is the listed applicant for UNIVERSITY HEALTH CARE PROCESSED ALTERNATING LEG PRESSURE (UHC APL) SLEEVE DEVICE?

The FDA 510(k) record lists University of Utah Hospitals and Clinics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNIVERSITY HEALTH CARE PROCESSED ALTERNATING LEG PRESSURE (UHC APL) SLEEVE DEVICE?

The FDA product code for UNIVERSITY HEALTH CARE PROCESSED ALTERNATING LEG PRESSURE (UHC APL) SLEEVE DEVICE is JOW.

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Other records listing University of Utah Hospitals and Clinics 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.

K031189UUHC REPROCESSED COMPRESSION SLEEVE DEVICES

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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