FDA 510(k)

HD60 Series Ultrasound Diagnostic System

Numéro K : K233439 · 2024-02-21

DemandeurQingdao Hisense Medical Equipment Co., Ltd.

Date de décision2024-02-21

Code produitIYN

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

HD60 Series Ultrasound Diagnostic System is the device name listed in this FDA 510(k) record. The listed applicant is Qingdao Hisense Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2024-02-21 under 510(k) number K233439. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the HD60 Series Ultrasound Diagnostic System?

HD60 Series Ultrasound Diagnostic System is a medical device that received FDA 510(k) clearance on 2024-02-21. The listed applicant is Qingdao Hisense Medical Equipment Co., Ltd.. The 510(k) number is K233439.

When did HD60 Series Ultrasound Diagnostic System receive FDA 510(k) clearance?

HD60 Series Ultrasound Diagnostic System received FDA 510(k) clearance on 2024-02-21, under 510(k) number K233439.

Who is the listed applicant for HD60 Series Ultrasound Diagnostic System?

The FDA 510(k) record lists Qingdao Hisense Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HD60 Series Ultrasound Diagnostic System?

The FDA product code for HD60 Series Ultrasound Diagnostic System is IYN.

Essais cliniques associés

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Autres dossiers indiquant Qingdao Hisense Medical Equipment Co., Ltd. en tant que demandeur

K233841HD80 Series Ultrasound Diagnostic System K222208Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D K222132Hisense LCD monitor HMD2G21S, HMD3G21S K221567LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)K213862HD60 Series Ultrasound Diagnostic System K160347Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21

Voir tous les 7 dispositifs →

Dispositifs connexes (Code : IYN)

Source officielle

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