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FDA 510(k)

Flowtron DVT5 Small Calf Garment

K-Number: K172103 · 2018-03-02

ApplicantGetinge (Suzhou) Co., Ltd.
Decision Date2018-03-02
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Flowtron DVT5 Small Calf Garment is the device name listed in this FDA 510(k) record. The listed applicant is Getinge (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2018-03-02 under 510(k) number K172103. 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 Flowtron DVT5 Small Calf Garment?

Flowtron DVT5 Small Calf Garment is a medical device that received FDA 510(k) clearance on 2018-03-02. The listed applicant is Getinge (Suzhou) Co., Ltd.. The 510(k) number is K172103.

When did Flowtron DVT5 Small Calf Garment receive FDA 510(k) clearance?

Flowtron DVT5 Small Calf Garment received FDA 510(k) clearance on 2018-03-02, under 510(k) number K172103.

Who is the listed applicant for Flowtron DVT5 Small Calf Garment?

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

What is the FDA product code for Flowtron DVT5 Small Calf Garment?

The FDA product code for Flowtron DVT5 Small Calf Garment is JOW.

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.

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Official Source

View on FDA Database →

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

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