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FDA 510(k)

Klinly Ultrasonic Tongue Cleaner

K-Number: K181986 · 2019-09-06

ApplicantKea Products, Ltd.
Decision Date2019-09-06
Product CodeQIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Klinly Ultrasonic Tongue Cleaner is the device name listed in this FDA 510(k) record. The listed applicant is Kea Products, Ltd.. It received FDA 510(k) clearance on 2019-09-06 under 510(k) number K181986. The device is classified under product code QIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Klinly Ultrasonic Tongue Cleaner?

Klinly Ultrasonic Tongue Cleaner is a medical device that received FDA 510(k) clearance on 2019-09-06. The listed applicant is Kea Products, Ltd.. The 510(k) number is K181986.

When did Klinly Ultrasonic Tongue Cleaner receive FDA 510(k) clearance?

Klinly Ultrasonic Tongue Cleaner received FDA 510(k) clearance on 2019-09-06, under 510(k) number K181986.

Who is the listed applicant for Klinly Ultrasonic Tongue Cleaner?

The FDA 510(k) record lists Kea Products, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Klinly Ultrasonic Tongue Cleaner?

The FDA product code for Klinly Ultrasonic Tongue Cleaner is QIA.

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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