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FDA 510(k)

AMBU MATIC AUTOMATIC RESUSCITATOR

K-Number: K904920 · 1991-05-28

ApplicantAmbu, Inc.
Decision Date1991-05-28
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AMBU MATIC AUTOMATIC RESUSCITATOR is the device name listed in this FDA 510(k) record. The listed applicant is Ambu, Inc.. It received FDA 510(k) clearance on 1991-05-28 under 510(k) number K904920. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMBU MATIC AUTOMATIC RESUSCITATOR?

AMBU MATIC AUTOMATIC RESUSCITATOR is a medical device that received FDA 510(k) clearance on 1991-05-28. The listed applicant is Ambu, Inc.. The 510(k) number is K904920.

When did AMBU MATIC AUTOMATIC RESUSCITATOR receive FDA 510(k) clearance?

AMBU MATIC AUTOMATIC RESUSCITATOR received FDA 510(k) clearance on 1991-05-28, under 510(k) number K904920.

Who is the listed applicant for AMBU MATIC AUTOMATIC RESUSCITATOR?

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 MATIC AUTOMATIC RESUSCITATOR?

The FDA product code for AMBU MATIC AUTOMATIC RESUSCITATOR is BTL.

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Other records listing Ambu, Inc. as applicant

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.

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Related Devices (Code: BTL)

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.

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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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