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FDA 510(k)

Smart-C

K-Number: K190024 · 2019-09-27

ApplicantTurner Imaging Systems, Inc.
Decision Date2019-09-27
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Smart-C is a medical device manufactured by Turner Imaging Systems, Inc.. It received FDA 510(k) clearance on 2019-09-27 under approval number K190024. The device is classified under product code OXO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Smart-C?

Smart-C is a medical device that received FDA 510(k) clearance on 2019-09-27. It is manufactured by Turner Imaging Systems, Inc.. The 510(k) number is K190024.

When was Smart-C approved by the FDA?

Smart-C received FDA 510(k) clearance on 2019-09-27, under approval number K190024.

What company makes Smart-C?

Smart-C is manufactured by Turner Imaging Systems, Inc..

What is the FDA product code for Smart-C?

The FDA product code for Smart-C is OXO.

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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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