FDA 510(k)

AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW

K-Number: K130845 · 2013-11-01

Decision Date2013-11-01

Product CodeEOQ

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW 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 2013-11-01 under 510(k) number K130845. 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 AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW?

AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW is a medical device that received FDA 510(k) clearance on 2013-11-01. The listed applicant is Ambu A/S. The 510(k) number is K130845.

When did AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW receive FDA 510(k) clearance?

AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW received FDA 510(k) clearance on 2013-11-01, under 510(k) number K130845.

Who is the listed applicant for AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW?

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 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW?

The FDA product code for AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ambu A/S as applicant

K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set K260578Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)K251583Ambu® Virobac II® Exhalation Filter K250269Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection)K240849Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2

View all 41 devices →

Related Devices (Code: EOQ)

K261637Single-use Flexible BronchoscopeHunan Vathin Medical Instrument Co., Ltd.K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/S K2540263.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U)Flexicare Medical Limited.K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.K254037LungFlow Airway CatheterFree Flow Medical, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm Corporation

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.