FDA 510(k)

SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25)

Numéro K : K220169 · 2022-10-11

Date de décision2022-10-11

Code produitIYN

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25) is the device name listed in this FDA 510(k) record. The listed applicant is Bionet Co., Ltd.. It received FDA 510(k) clearance on 2022-10-11 under 510(k) number K220169. 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 SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25)?

SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25) is a medical device that received FDA 510(k) clearance on 2022-10-11. The listed applicant is Bionet Co., Ltd.. The 510(k) number is K220169.

When did SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25) receive FDA 510(k) clearance?

SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25) received FDA 510(k) clearance on 2022-10-11, under 510(k) number K220169.

Who is the listed applicant for SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25)?

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

What is the FDA product code for SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25)?

The FDA product code for SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25) is IYN.

Essais cliniques associés

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Autres dossiers indiquant Bionet Co., Ltd. en tant que demandeur

K231160Cardio Q50, Cardio Q70 K231150Cardio P1 K220535Cardio10

Dispositifs connexes (Code : IYN)

Source officielle

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