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FDA 510(k)

Single-Use Video Bronchoscopes, Digital Controller

K-Number: K213782 · 2022-07-08

ApplicantMicro-Tech (Nanjing) Co., Lts
Decision Date2022-07-08
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Single-Use Video Bronchoscopes, Digital Controller is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Tech (Nanjing) Co., Lts. It received FDA 510(k) clearance on 2022-07-08 under 510(k) number K213782. 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 Single-Use Video Bronchoscopes, Digital Controller?

Single-Use Video Bronchoscopes, Digital Controller is a medical device that received FDA 510(k) clearance on 2022-07-08. The listed applicant is Micro-Tech (Nanjing) Co., Lts. The 510(k) number is K213782.

When did Single-Use Video Bronchoscopes, Digital Controller receive FDA 510(k) clearance?

Single-Use Video Bronchoscopes, Digital Controller received FDA 510(k) clearance on 2022-07-08, under 510(k) number K213782.

Who is the listed applicant for Single-Use Video Bronchoscopes, Digital Controller?

The FDA 510(k) record lists Micro-Tech (Nanjing) Co., Lts as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single-Use Video Bronchoscopes, Digital Controller?

The FDA product code for Single-Use Video Bronchoscopes, Digital Controller is EOQ.

Related Clinical Trials

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.

NCT07557147Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-MonitorNOT_YET_RECRUITING

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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