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System, Imaging, Pulsed Doppler, Ultrasonic

FDA product code IYN · 1075 cleared devices

Class 2 Radiology
Regulation
21 CFR 892.1550
Review panel
RA
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
1978-10-10 – 2026-09-25
IYN 2024-09-11

Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging

Applicant Leltek, Inc.

K number K241161

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