FDA 510(k)

AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC

K-Number: K102824 · 2011-01-28

Decision Date2011-01-28

Product CodeBTM

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC 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 2011-01-28 under 510(k) number K102824. The device is classified under product code BTM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC?

AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC is a medical device that received FDA 510(k) clearance on 2011-01-28. The listed applicant is Ambu A/S. The 510(k) number is K102824.

When did AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC receive FDA 510(k) clearance?

AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC received FDA 510(k) clearance on 2011-01-28, under 510(k) number K102824.

Who is the listed applicant for AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC?

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 OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC?

The FDA product code for AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC is BTM.

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: BTM)

K251631The BAG manual resuscitator and accessoriesLaerdal Medical AS K243861butterflyBVMCompact Medical, Inc.K221841EOlife®Archeon K212905Sotair DeviceSafe Bvm Corporation K210288Disposable Manual ResuscitatorXiamen Compower Medical Tech. Co., Ltd.K181583Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20Flexicare Medical Limited.

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.