FDA 510(k)

Revolution Maxima, Revolution Ace

K-Number: K192686 · 2019-10-24

ApplicantGe Hangwei Medical Systems Co., Ltd.

Decision Date2019-10-24

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Revolution Maxima, Revolution Ace is a medical device manufactured by Ge Hangwei Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2019-10-24 under approval number K192686. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Revolution Maxima, Revolution Ace?

Revolution Maxima, Revolution Ace is a medical device that received FDA 510(k) clearance on 2019-10-24. It is manufactured by Ge Hangwei Medical Systems Co., Ltd.. The 510(k) number is K192686.

When was Revolution Maxima, Revolution Ace approved by the FDA?

Revolution Maxima, Revolution Ace received FDA 510(k) clearance on 2019-10-24, under approval number K192686.

What company makes Revolution Maxima, Revolution Ace?

Revolution Maxima, Revolution Ace is manufactured by Ge Hangwei Medical Systems Co., Ltd..

What is the FDA product code for Revolution Maxima, Revolution Ace?

The FDA product code for Revolution Maxima, Revolution Ace is JAK.

Other Devices by Ge Hangwei Medical Systems Co., Ltd.

K160131OEC Elite MiniView K171013Revolution ACT K192956Auto Positioning K233749Revolution Ascend Sliding

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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.