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510(k) K151709

Hi-Light Diagnostic Ultrasound Systems by Qingdao Hisense Medical Equipment Co., Ltd. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2015
Date Received
June 24, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

Other clearances by Qingdao Hisense Medical Equipment Co., Ltd.

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  • K222132 — Hisense LCD monitor HMD2G21S, HMD3G21S (November 8, 2022)
  • K221567 — LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) (July 26, 2022)
  • K213862 — HD60 Series Ultrasound Diagnostic System (June 8, 2022)
  • K160347 — Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21 (March 3, 2016)
  • K152030 — Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) (September 16, 2015)

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