FDA 510(k)

AMBU TUBECHECK

K-Number: K981891 · 1998-07-17

Decision Date1998-07-17

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

AMBU TUBECHECK is the device name listed in this FDA 510(k) record. The listed applicant is Ambu, Inc.. It received FDA 510(k) clearance on 1998-07-17 under 510(k) number K981891. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMBU TUBECHECK?

AMBU TUBECHECK is a medical device that received FDA 510(k) clearance on 1998-07-17. The listed applicant is Ambu, Inc.. The 510(k) number is K981891.

When did AMBU TUBECHECK receive FDA 510(k) clearance?

AMBU TUBECHECK received FDA 510(k) clearance on 1998-07-17, under 510(k) number K981891.

Who is the listed applicant for AMBU TUBECHECK?

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 TUBECHECK?

The FDA product code for AMBU TUBECHECK is BTR.

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Related Devices (Code: BTR)

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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.