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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 the device name listed in this FDA 510(k) record. The listed applicant is Jeil Medical Corporation. It received FDA 510(k) clearance on 2016-12-27 under 510(k) 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. The listed applicant is Jeil Medical Corporation. The 510(k) number is K163308.

When did SMARTO receive FDA 510(k) clearance?

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

Who is the listed applicant for SMARTO?

The FDA 510(k) record lists Jeil Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMARTO?

The FDA product code for SMARTO is KIJ.

Other records listing Jeil Medical Corporation as applicant

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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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