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FDA 510(k)

AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD

K-Number: K982722 · 1999-04-12

ApplicantAmbu, Inc.
Decision Date1999-04-12
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD is the device name listed in this FDA 510(k) record. The listed applicant is Ambu, Inc.. It received FDA 510(k) clearance on 1999-04-12 under 510(k) number K982722. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD?

AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD is a medical device that received FDA 510(k) clearance on 1999-04-12. The listed applicant is Ambu, Inc.. The 510(k) number is K982722.

When did AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD receive FDA 510(k) clearance?

AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD received FDA 510(k) clearance on 1999-04-12, under 510(k) number K982722.

Who is the listed applicant for AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD?

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

What is the FDA product code for AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD?

The FDA product code for AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD is CAF.

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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.

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