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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K210432
Device Name LELTEK Ultrasound Imaging System (Model: LU700 Series)
Applicant
Leltek, Inc.
6f.-3, #293, Sec 1, Beixin Rd., Xindian Dist.,
New Taipei City,  TW 23147
Applicant Contact Jessie Wang
Correspondent
Leltek, Inc.
6f.-3, #293, Sec 1, Beixin Rd., Xindian Dist.,
New Taipei City,  TW 23147
Correspondent Contact Jessie Wang
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received02/12/2021
Decision Date 11/03/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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