Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Ambu A/S. It received FDA 510(k) clearance on 2019-05-22 under approval 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. It is manufactured by Ambu A/S. The 510(k) number is K191080.

When was Ambu aScope 4 RhinoLaryngo Slim approved by the FDA?

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

What company makes Ambu aScope 4 RhinoLaryngo Slim?

Ambu aScope 4 RhinoLaryngo Slim is manufactured by Ambu A/S.

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

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

Other Devices by Ambu A/S

K161656Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor K152931Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator K160766Ambu USR, Ambu M K181286Ambu aScope RLS Slim K173727Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor K190972Ambu aScope 4 RhinoLaryngo Intervention

View all 26 devices →

Related Devices (Code: EOB)

K153701ULYSS Multi View SinuscopeSopro-Comeg GmbH K153009ULTRA TelescopesOlympus Winter & Ibe GmbH K152531InstaClear Lens CleanerGyrus Acmi, Inc. K170453Medrobotics Flex Robotic SystemMedrobotics Corporation K161298ShenDa SinuscopeShenyang Shenda Endoscope Co., Ltd. K170285AED SinuscopeNational Advanced Endoscopy Devices, 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.

↑