FDA 510(k)

Hydroven 12, Hydroven 12 Garments

K-Number: K152228 · 2016-04-04

Decision Date2016-04-04

Product CodeJOW

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Hydroven 12, Hydroven 12 Garments is a medical device manufactured by Huntleigh Healthcare , Ltd.. It received FDA 510(k) clearance on 2016-04-04 under approval number K152228. 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 Hydroven 12, Hydroven 12 Garments?

Hydroven 12, Hydroven 12 Garments is a medical device that received FDA 510(k) clearance on 2016-04-04. It is manufactured by Huntleigh Healthcare , Ltd.. The 510(k) number is K152228.

When was Hydroven 12, Hydroven 12 Garments approved by the FDA?

Hydroven 12, Hydroven 12 Garments received FDA 510(k) clearance on 2016-04-04, under approval number K152228.

What company makes Hydroven 12, Hydroven 12 Garments?

Hydroven 12, Hydroven 12 Garments is manufactured by Huntleigh Healthcare , Ltd..

What is the FDA product code for Hydroven 12, Hydroven 12 Garments?

The FDA product code for Hydroven 12, Hydroven 12 Garments is JOW.

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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.