FDA 510(k)

AMBU MARK IV BABY RESUSCITATOR

K-Number: K053142 · 2005-12-20

Decision Date2005-12-20

Product CodeBTM

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

AMBU MARK IV BABY RESUSCITATOR 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 2005-12-20 under 510(k) number K053142. 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 MARK IV BABY RESUSCITATOR?

AMBU MARK IV BABY RESUSCITATOR is a medical device that received FDA 510(k) clearance on 2005-12-20. The listed applicant is Ambu A/S. The 510(k) number is K053142.

When did AMBU MARK IV BABY RESUSCITATOR receive FDA 510(k) clearance?

AMBU MARK IV BABY RESUSCITATOR received FDA 510(k) clearance on 2005-12-20, under 510(k) number K053142.

Who is the listed applicant for AMBU MARK IV BABY RESUSCITATOR?

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 MARK IV BABY RESUSCITATOR?

The FDA product code for AMBU MARK IV BABY RESUSCITATOR is BTM.

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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

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Related Devices (Code: BTM)

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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.