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FDA 510(k)

LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)

K-Number: K221567 · 2022-07-26

ApplicantQingdao Hisense Medical Equipment Co., Ltd.
Decision Date2022-07-26
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) is a medical device manufactured by Qingdao Hisense Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2022-07-26 under approval number K221567. The device is classified under product code PGY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)?

LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) is a medical device that received FDA 510(k) clearance on 2022-07-26. It is manufactured by Qingdao Hisense Medical Equipment Co., Ltd.. The 510(k) number is K221567.

When was LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) approved by the FDA?

LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) received FDA 510(k) clearance on 2022-07-26, under approval number K221567.

What company makes LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)?

LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) is manufactured by Qingdao Hisense Medical Equipment Co., Ltd..

What is the FDA product code for LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)?

The FDA product code for LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) is PGY.

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 K213862HD60 Series Ultrasound Diagnostic System K233841HD80 Series Ultrasound Diagnostic System K233439HD60 Series Ultrasound Diagnostic System

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Related Devices (Code: PGY)

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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.

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