FDA 510(k)

Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)

Numéro K : K241979 · 2024-08-22

DemandeurBeijing Konted Medical Technology Co.,Ltd

Date de décision2024-08-22

Code produitIYN

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro) is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Konted Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2024-08-22 under 510(k) number K241979. 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 Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)?

Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro) is a medical device that received FDA 510(k) clearance on 2024-08-22. The listed applicant is Beijing Konted Medical Technology Co.,Ltd. The 510(k) number is K241979.

When did Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro) receive FDA 510(k) clearance?

Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro) received FDA 510(k) clearance on 2024-08-22, under 510(k) number K241979.

Who is the listed applicant for Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)?

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

What is the FDA product code for Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)?

The FDA product code for Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro) is IYN.

Essais cliniques associés

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Autres dossiers indiquant Beijing Konted Medical Technology Co.,Ltd en tant que demandeur

K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)K231354Pocket Ultrasound System (C10)

Dispositifs connexes (Code : IYN)

Source officielle

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