FDA 510(k)

AnyCheck IMT-100

K-Number: K180953 · 2019-02-20

Decision Date2019-02-20

Product CodeEKX

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

AnyCheck IMT-100 is the device name listed in this FDA 510(k) record. The listed applicant is Dms Co., Ltd.. It received FDA 510(k) clearance on 2019-02-20 under 510(k) number K180953. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AnyCheck IMT-100?

AnyCheck IMT-100 is a medical device that received FDA 510(k) clearance on 2019-02-20. The listed applicant is Dms Co., Ltd.. The 510(k) number is K180953.

When did AnyCheck IMT-100 receive FDA 510(k) clearance?

AnyCheck IMT-100 received FDA 510(k) clearance on 2019-02-20, under 510(k) number K180953.

Who is the listed applicant for AnyCheck IMT-100?

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

What is the FDA product code for AnyCheck IMT-100?

The FDA product code for AnyCheck IMT-100 is EKX.

Related Devices (Code: EKX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252223Alpha Endo Handpiece (Alpha Endo)SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.K251597InnerView SystemPerimetrics, Inc.K243692EnDrive (EnDriveUS)Advanced Technology Research (A.T.R.) S.R.L.K242514Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)Shenzhen Rogin Medical Co., Ltd.K241065ChecQ (AC100)Dentis Co., Ltd.K243911HPR Cordless Hygiene HandpieceHandpiece Headquarters

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.