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FDA 510(k)

Ambu aScope 4 RhinoLaryngo Slim

K-Number: K191080 · 2019-05-22

ApplicantAmbu A/S
Decision Date2019-05-22
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Ambu aScope 4 RhinoLaryngo Slim is the device name listed in this FDA 510(k) record. The listed applicant is Ambu A/S. It received FDA 510(k) clearance on 2019-05-22 under 510(k) number K191080. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ambu aScope 4 RhinoLaryngo Slim?

Ambu aScope 4 RhinoLaryngo Slim is a medical device that received FDA 510(k) clearance on 2019-05-22. The listed applicant is Ambu A/S. The 510(k) number is K191080.

When did Ambu aScope 4 RhinoLaryngo Slim receive FDA 510(k) clearance?

Ambu aScope 4 RhinoLaryngo Slim received FDA 510(k) clearance on 2019-05-22, under 510(k) number K191080.

Who is the listed applicant for Ambu aScope 4 RhinoLaryngo Slim?

The FDA 510(k) record lists Ambu A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ambu aScope 4 RhinoLaryngo Slim?

The FDA product code for Ambu aScope 4 RhinoLaryngo Slim is EOB.

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Related Devices (Code: EOB)

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.

K261544Hydro Irrigation SystemStryker InstrumentsK254133ENTity USB Videoscope SystemOptim, LLCK253184Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)Zhuhai Wesee Meditech Co., Ltd.K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DOlympus Medical Systems CorporationK241731Outlook Surgical Versa One System (8900139)Resnent, LLCK243639Portare System (FA-001)Grumpy Innovation, Inc.

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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