FDA 510(k)

SonoMax Series Digital Color Doppler Ultrasound System

Numéro K : K233697 · 2024-08-09

DemandeurCHISON Medical Technologies Co., Ltd.

Date de décision2024-08-09

Code produitIYN

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

SonoMax Series Digital Color Doppler Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is CHISON Medical Technologies Co., Ltd.. It received FDA 510(k) clearance on 2024-08-09 under 510(k) number K233697. 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 SonoMax Series Digital Color Doppler Ultrasound System?

SonoMax Series Digital Color Doppler Ultrasound System is a medical device that received FDA 510(k) clearance on 2024-08-09. The listed applicant is CHISON Medical Technologies Co., Ltd.. The 510(k) number is K233697.

When did SonoMax Series Digital Color Doppler Ultrasound System receive FDA 510(k) clearance?

SonoMax Series Digital Color Doppler Ultrasound System received FDA 510(k) clearance on 2024-08-09, under 510(k) number K233697.

Who is the listed applicant for SonoMax Series Digital Color Doppler Ultrasound System?

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

What is the FDA product code for SonoMax Series Digital Color Doppler Ultrasound System?

The FDA product code for SonoMax Series Digital Color Doppler Ultrasound System is IYN.

Essais cliniques associés

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Autres dossiers indiquant CHISON Medical Technologies Co., Ltd. en tant que demandeur

K253949SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6 K223570SonoAir Series Digital Color Doppler Ultrasound System K202457M1 Surgical Face Mask K201965SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System K201967SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System K201968SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System

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Dispositifs connexes (Code : IYN)

Source officielle

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