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FDA 510(k)

Venera 508 Deep Vein Thrombosis (DVT) Prevention System

K-Number: K180389 · 2018-06-29

ApplicantSuzhou Minhua Medical Apparatus Supplies Co., Ltd.
Decision Date2018-06-29
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Venera 508 Deep Vein Thrombosis (DVT) Prevention System is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Minhua Medical Apparatus Supplies Co., Ltd.. It received FDA 510(k) clearance on 2018-06-29 under 510(k) number K180389. 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 Venera 508 Deep Vein Thrombosis (DVT) Prevention System?

Venera 508 Deep Vein Thrombosis (DVT) Prevention System is a medical device that received FDA 510(k) clearance on 2018-06-29. The listed applicant is Suzhou Minhua Medical Apparatus Supplies Co., Ltd.. The 510(k) number is K180389.

When did Venera 508 Deep Vein Thrombosis (DVT) Prevention System receive FDA 510(k) clearance?

Venera 508 Deep Vein Thrombosis (DVT) Prevention System received FDA 510(k) clearance on 2018-06-29, under 510(k) number K180389.

Who is the listed applicant for Venera 508 Deep Vein Thrombosis (DVT) Prevention System?

The FDA 510(k) record lists Suzhou Minhua Medical Apparatus Supplies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Venera 508 Deep Vein Thrombosis (DVT) Prevention System?

The FDA product code for Venera 508 Deep Vein Thrombosis (DVT) Prevention System is JOW.

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Other records listing Suzhou Minhua Medical Apparatus Supplies Co., 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.

K241096Venera 608 Deep Vein Thrombosis (DVT) Prevention SystemK233276Reusable Blood Pressure CuffK171889Reusable Blood Pressure Cuff

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.

K253555Flexitouch® 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.K250974Bio Arterial Deluxe (IC-BAP-DX)Bio Compression Systems, Inc.K250190Sequential Compression System (SCD600)Shenzhen Comen Medical Instruments Co.,Ltd

Official Source

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