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FDA 510(k)

Scanmate Flex

K-Number: K171301 · 2017-07-31

ApplicantDgh Technology, Inc.
Decision Date2017-07-31
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Scanmate Flex is a medical device manufactured by Dgh Technology, Inc.. It received FDA 510(k) clearance on 2017-07-31 under approval number K171301. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Scanmate Flex?

Scanmate Flex is a medical device that received FDA 510(k) clearance on 2017-07-31. It is manufactured by Dgh Technology, Inc.. The 510(k) number is K171301.

When was Scanmate Flex approved by the FDA?

Scanmate Flex received FDA 510(k) clearance on 2017-07-31, under approval number K171301.

What company makes Scanmate Flex?

Scanmate Flex is manufactured by Dgh Technology, Inc..

What is the FDA product code for Scanmate Flex?

The FDA product code for Scanmate Flex is IYO.

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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.

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