FDA 510(k)

DDAT OMT

K-Number: K050098 · 2005-05-23

Decision Date2005-05-23

Product CodeGWN

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

DDAT OMT is the device name listed in this FDA 510(k) record. The listed applicant is Ddat(Uk), Ltd.. It received FDA 510(k) clearance on 2005-05-23 under 510(k) number K050098. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DDAT OMT?

DDAT OMT is a medical device that received FDA 510(k) clearance on 2005-05-23. The listed applicant is Ddat(Uk), Ltd.. The 510(k) number is K050098.

When did DDAT OMT receive FDA 510(k) clearance?

DDAT OMT received FDA 510(k) clearance on 2005-05-23, under 510(k) number K050098.

Who is the listed applicant for DDAT OMT?

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

What is the FDA product code for DDAT OMT?

The FDA product code for DDAT OMT is GWN.

Related Devices (Code: GWN)

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.

K260566SMARTVERTIGO™ Vestibular Assessment SystemVertigoDx, Inc.K243709NeuroEars-Anna™Neuroears, Inc.K242198ICS Dizcovery (1091)Natus Medical Denmark Aps K242726Synapsys VHITInventis S.R.L.K223047NeuroSwift ProNeurobit Technologies Co., Ltd.K203082Insight Infrared Video GogglesVestibular First

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.