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FDA 510(k)

STAR 65

K-Number: K172147 · 2018-05-25

ApplicantSkanray Technologies Pvt, Ltd.
Decision Date2018-05-25
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STAR 65 is a medical device manufactured by Skanray Technologies Pvt, Ltd.. It received FDA 510(k) clearance on 2018-05-25 under approval number K172147. 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 65?

STAR 65 is a medical device that received FDA 510(k) clearance on 2018-05-25. It is manufactured by Skanray Technologies Pvt, Ltd.. The 510(k) number is K172147.

When was STAR 65 approved by the FDA?

STAR 65 received FDA 510(k) clearance on 2018-05-25, under approval number K172147.

What company makes STAR 65?

STAR 65 is manufactured by Skanray Technologies Pvt, Ltd..

What is the FDA product code for STAR 65?

The FDA product code for STAR 65 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.

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