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FDA 510(k)

V-PRO® 1 Plus and V-PRO® maX Low Temperature

K-Number: K160433 · 2016-07-06

Decision Date2016-07-06
Product CodeMLR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

V-PRO® 1 Plus and V-PRO® maX Low Temperature is a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2016-07-06 under approval number K160433. The device is classified under product code MLR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the V-PRO® 1 Plus and V-PRO® maX Low Temperature?

V-PRO® 1 Plus and V-PRO® maX Low Temperature is a medical device that received FDA 510(k) clearance on 2016-07-06. It is manufactured by STERIS Corporation. The 510(k) number is K160433.

When was V-PRO® 1 Plus and V-PRO® maX Low Temperature approved by the FDA?

V-PRO® 1 Plus and V-PRO® maX Low Temperature received FDA 510(k) clearance on 2016-07-06, under approval number K160433.

What company makes V-PRO® 1 Plus and V-PRO® maX Low Temperature?

V-PRO® 1 Plus and V-PRO® maX Low Temperature is manufactured by STERIS Corporation.

What is the FDA product code for V-PRO® 1 Plus and V-PRO® maX Low Temperature?

The FDA product code for V-PRO® 1 Plus and V-PRO® maX Low Temperature is MLR.

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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.