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FDA 510(k)

SMARTO

K-Number: K163308 · 2016-12-27

ApplicantJeil Medical Corporation
Decision Date2016-12-27
Product CodeKIJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SMARTO is a medical device manufactured by Jeil Medical Corporation. It received FDA 510(k) clearance on 2016-12-27 under approval number K163308. The device is classified under product code KIJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMARTO?

SMARTO is a medical device that received FDA 510(k) clearance on 2016-12-27. It is manufactured by Jeil Medical Corporation. The 510(k) number is K163308.

When was SMARTO approved by the FDA?

SMARTO received FDA 510(k) clearance on 2016-12-27, under approval number K163308.

What company makes SMARTO?

SMARTO is manufactured by Jeil Medical Corporation.

What is the FDA product code for SMARTO?

The FDA product code for SMARTO is KIJ.

Other Devices by Jeil Medical Corporation

K161746ARIX Hand System K161864ARIX Foot System K151468ARIX Wrist System K172008ARIX Humerus System K170705ARIX Wrist System K170368Sterile NS System

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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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