Revolution ACT
K-Number: K171013 · 2017-06-05
ApplicantGe Hangwei Medical Systems Co., Ltd.
Decision Date2017-06-05
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Revolution ACT is a medical device manufactured by Ge Hangwei Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2017-06-05 under approval number K171013. 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 ACT?
Revolution ACT is a medical device that received FDA 510(k) clearance on 2017-06-05. It is manufactured by Ge Hangwei Medical Systems Co., Ltd.. The 510(k) number is K171013.
When was Revolution ACT approved by the FDA?
Revolution ACT received FDA 510(k) clearance on 2017-06-05, under approval number K171013.
What company makes Revolution ACT?
Revolution ACT is manufactured by Ge Hangwei Medical Systems Co., Ltd..
What is the FDA product code for Revolution ACT?
The FDA product code for Revolution ACT is JAK.
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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.