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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 the device name listed in this FDA 510(k) record. The listed applicant is Dgh Technology, Inc.. It received FDA 510(k) clearance on 2017-07-31 under 510(k) 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. The listed applicant is Dgh Technology, Inc.. The 510(k) number is K171301.

When did Scanmate Flex receive FDA 510(k) clearance?

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

Who is the listed applicant for Scanmate Flex?

The FDA 510(k) record lists Dgh Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Scanmate Flex?

The FDA product code for Scanmate Flex is IYO.

Related Devices (Code: IYO)

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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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