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510(k) K213862

HD60 Series Ultrasound Diagnostic System by Qingdao Hisense Medical Equipment Co., Ltd. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2022
Date Received
December 10, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type

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

  • K233841 — HD80 Series Ultrasound Diagnostic System (May 16, 2024)
  • K233439 — HD60 Series Ultrasound Diagnostic System (February 21, 2024)
  • K222208 — Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D (November 17, 2022)
  • K222132 — Hisense LCD monitor HMD2G21S, HMD3G21S (November 8, 2022)
  • K221567 — LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) (July 26, 2022)
  • K160347 — Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21 (March 3, 2016)
  • K152030 — Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) (September 16, 2015)
  • K151709 — Hi-Light Diagnostic Ultrasound Systems (July 17, 2015)

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