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FDA 510(k)

ULTIMA AIRFLOW SENSOR, 0510

K-Number: K981445 · 1998-10-05

ApplicantBraebon Medical Corp.
Decision Date1998-10-05
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ULTIMA AIRFLOW SENSOR, 0510 is the device name listed in this FDA 510(k) record. The listed applicant is Braebon Medical Corp.. It received FDA 510(k) clearance on 1998-10-05 under 510(k) number K981445. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTIMA AIRFLOW SENSOR, 0510?

ULTIMA AIRFLOW SENSOR, 0510 is a medical device that received FDA 510(k) clearance on 1998-10-05. The listed applicant is Braebon Medical Corp.. The 510(k) number is K981445.

When did ULTIMA AIRFLOW SENSOR, 0510 receive FDA 510(k) clearance?

ULTIMA AIRFLOW SENSOR, 0510 received FDA 510(k) clearance on 1998-10-05, under 510(k) number K981445.

Who is the listed applicant for ULTIMA AIRFLOW SENSOR, 0510?

The FDA 510(k) record lists Braebon Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTIMA AIRFLOW SENSOR, 0510?

The FDA product code for ULTIMA AIRFLOW SENSOR, 0510 is BZQ.

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Other records listing Braebon Medical Corp. 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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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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