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FDA 510(k)

Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6)

Numéro K : K243132 · 2024-12-10

DemandeurShantou Institute of Ultrasonic Instruments Co., Ltd.
Date de décision2024-12-10
Code produitIYN
Comité consultatifRA
DécisionSubstantially Equivalent

Résumé du dispositif

Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6) is the device name listed in this FDA 510(k) record. The listed applicant is Shantou Institute of Ultrasonic Instruments Co., Ltd.. It received FDA 510(k) clearance on 2024-12-10 under 510(k) number K243132. 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 Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6)?

Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6) is a medical device that received FDA 510(k) clearance on 2024-12-10. The listed applicant is Shantou Institute of Ultrasonic Instruments Co., Ltd.. The 510(k) number is K243132.

When did Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6) receive FDA 510(k) clearance?

Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6) received FDA 510(k) clearance on 2024-12-10, under 510(k) number K243132.

Who is the listed applicant for Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6)?

The FDA 510(k) record lists Shantou Institute of Ultrasonic Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6)?

The FDA product code for Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6) is IYN.

Essais cliniques associés

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Autres dossiers indiquant Shantou Institute of Ultrasonic Instruments Co., Ltd. en tant que demandeur

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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Dispositifs connexes (Code : IYN)

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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