Star 60
K-Number: K151512 · 2016-02-14
ApplicantSkanray Technologies Private Limited
Decision Date2016-02-14
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Star 60 is a medical device manufactured by Skanray Technologies Private Limited. It received FDA 510(k) clearance on 2016-02-14 under approval number K151512. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Star 60?
Star 60 is a medical device that received FDA 510(k) clearance on 2016-02-14. It is manufactured by Skanray Technologies Private Limited. The 510(k) number is K151512.
When was Star 60 approved by the FDA?
Star 60 received FDA 510(k) clearance on 2016-02-14, under approval number K151512.
What company makes Star 60?
Star 60 is manufactured by Skanray Technologies Private Limited.
What is the FDA product code for Star 60?
The FDA product code for Star 60 is MWI.
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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.