LELTEK Ultrasound Imaging System (Model: LU700 Series)

System, Imaging, Pulsed Doppler, Ultrasonic

Leltek Inc

The following data is part of a premarket notification filed by Leltek Inc with the FDA for Leltek Ultrasound Imaging System (model: Lu700 Series).

Pre-market Notification Details

Device IDK210432
510k NumberK210432
Device Name:LELTEK Ultrasound Imaging System (Model: LU700 Series)
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Leltek Inc 6F-3., No. 293, Sec. 1, Beixin Rd., Xindian Dist., New Taipei City,  TW 23147
ContactJessie Wang
CorrespondentJessie Wang
Leltek Inc 6F-3., No. 293, Sec. 1, Beixin Rd., Xindian Dist., New Taipei City,  TW 23147
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-12
Decision Date2021-11-03

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