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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 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 2022-02-28 under 510(k) 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. The listed applicant is Hunan Vathin Medical Instrument Co., Ltd.. The 510(k) number is K213635.

When did Vathin Video Bronchoscope System receive FDA 510(k) clearance?

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

Who is the listed applicant for Vathin Video Bronchoscope System?

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 Vathin Video Bronchoscope System?

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

Other records listing Hunan Vathin Medical Instrument Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250232Vathin® Video Bronchoscope SystemK251599Single-use Ureteral Access SheathK250785Single-use Flexible UreteroscopeK243117Digital Video ProcessorK242416Single-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-50mLK242535Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2)

View all 17 devices →

Related Devices (Code: EOQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.K254037LungFlow Airway CatheterFree Flow Medical, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm CorporationK260565SmartClip Delivery Catheter (ADR-1715)Elucent MedicalK252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)Olympus Medical Systems Corp.K260420LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)MacroLux Medical Technology Co., Ltd.

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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