FDA 510(k)

Single-use Flexible Rhinolaryngoscope; Digital Video Monitor

Numéro K : K230536 · 2023-06-14

DemandeurHunan Vathin Medical Instrument Co., Ltd.

Date de décision2023-06-14

Code produitEOB

Comité consultatifEN

DécisionSubstantially Equivalent

Résumé du dispositif

Single-use Flexible Rhinolaryngoscope; Digital Video Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Hunan Vathin Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2023-06-14 under 510(k) number K230536. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Single-use Flexible Rhinolaryngoscope; Digital Video Monitor?

Single-use Flexible Rhinolaryngoscope; Digital Video Monitor is a medical device that received FDA 510(k) clearance on 2023-06-14. The listed applicant is Hunan Vathin Medical Instrument Co., Ltd.. The 510(k) number is K230536.

When did Single-use Flexible Rhinolaryngoscope; Digital Video Monitor receive FDA 510(k) clearance?

Single-use Flexible Rhinolaryngoscope; Digital Video Monitor received FDA 510(k) clearance on 2023-06-14, under 510(k) number K230536.

Who is the listed applicant for Single-use Flexible Rhinolaryngoscope; Digital Video Monitor?

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

What is the FDA product code for Single-use Flexible Rhinolaryngoscope; Digital Video Monitor?

The FDA product code for Single-use Flexible Rhinolaryngoscope; Digital Video Monitor is EOB.

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Autres dossiers indiquant Hunan Vathin Medical Instrument Co., Ltd. en tant que demandeur

K261637Single-use Flexible Bronchoscope K250232Vathin® Video Bronchoscope System K251599Single-use Ureteral Access Sheath K250785Single-use Flexible Ureteroscope K243117Digital Video Processor K242416Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL

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Source officielle

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