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FDA 510(k)

AeroDVx System

K-Number: K183349 · 2019-07-19

ApplicantSun Scientific, Inc.
Decision Date2019-07-19
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AeroDVx System is the device name listed in this FDA 510(k) record. The listed applicant is Sun Scientific, Inc.. It received FDA 510(k) clearance on 2019-07-19 under 510(k) number K183349. 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 AeroDVx System?

AeroDVx System is a medical device that received FDA 510(k) clearance on 2019-07-19. The listed applicant is Sun Scientific, Inc.. The 510(k) number is K183349.

When did AeroDVx System receive FDA 510(k) clearance?

AeroDVx System received FDA 510(k) clearance on 2019-07-19, under 510(k) number K183349.

Who is the listed applicant for AeroDVx System?

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

What is the FDA product code for AeroDVx System?

The FDA product code for AeroDVx System is JOW.

Other records listing Sun Scientific, Inc. 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.

K222823AeroDVx Arm 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.

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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