HD60 Series Ultrasound Diagnostic System
K-Number: K213862 · 2022-06-08
Decision Date2022-06-08
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
HD60 Series Ultrasound Diagnostic System is a medical device manufactured by Qingdao Hisense Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2022-06-08 under approval number K213862. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HD60 Series Ultrasound Diagnostic System?
HD60 Series Ultrasound Diagnostic System is a medical device that received FDA 510(k) clearance on 2022-06-08. It is manufactured by Qingdao Hisense Medical Equipment Co., Ltd.. The 510(k) number is K213862.
When was HD60 Series Ultrasound Diagnostic System approved by the FDA?
HD60 Series Ultrasound Diagnostic System received FDA 510(k) clearance on 2022-06-08, under approval number K213862.
What company makes HD60 Series Ultrasound Diagnostic System?
HD60 Series Ultrasound Diagnostic System is manufactured by Qingdao Hisense Medical Equipment Co., Ltd..
What is the FDA product code for HD60 Series Ultrasound Diagnostic System?
The FDA product code for HD60 Series Ultrasound Diagnostic System is IYN.
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Other Devices by Qingdao Hisense Medical Equipment Co., Ltd.
K160347Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21
K222208Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D
K222132Hisense LCD monitor HMD2G21S, HMD3G21S
K221567LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)
K233841HD80 Series Ultrasound Diagnostic System
K233439HD60 Series Ultrasound Diagnostic System
Related Devices (Code: IYN)
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.