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FDA 510(k)

Vathin Video Bronchoscope System

K-Number: K213635 · 2022-02-28

ApplicantHunan Vathin Medical Instrument Co., Ltd.
Decision Date2022-02-28
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Vathin Video Bronchoscope System is a medical device manufactured by Hunan Vathin Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2022-02-28 under approval number K213635. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vathin Video Bronchoscope System?

Vathin Video Bronchoscope System is a medical device that received FDA 510(k) clearance on 2022-02-28. It is manufactured by Hunan Vathin Medical Instrument Co., Ltd.. The 510(k) number is K213635.

When was Vathin Video Bronchoscope System approved by the FDA?

Vathin Video Bronchoscope System received FDA 510(k) clearance on 2022-02-28, under approval number K213635.

What company makes Vathin Video Bronchoscope System?

Vathin Video Bronchoscope System is manufactured by Hunan Vathin Medical Instrument Co., Ltd..

What is the FDA product code for Vathin Video Bronchoscope System?

The FDA product code for Vathin Video Bronchoscope System is EOQ.

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Related PubMed Literature

PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025)

Other Devices by Hunan Vathin Medical Instrument Co., Ltd.

K191828Vathin Video Bronchoscope System K221581Single-Use Flexible Rhinolaryngoscope K221580Single-Use Flexible Cystoscope K230536Single-use Flexible Rhinolaryngoscope; Digital Video Monitor K230200Single-Use Flexible Ureteroscope K223836Vathin® Video Bronchoscope System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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