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FDA 510(k)

EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170

K-Number: K913749 · 1992-07-02

ApplicantEdentec Corp.
Decision Date1992-07-02
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170 is the device name listed in this FDA 510(k) record. The listed applicant is Edentec Corp.. It received FDA 510(k) clearance on 1992-07-02 under 510(k) number K913749. 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 EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170?

EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170 is a medical device that received FDA 510(k) clearance on 1992-07-02. The listed applicant is Edentec Corp.. The 510(k) number is K913749.

When did EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170 receive FDA 510(k) clearance?

EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170 received FDA 510(k) clearance on 1992-07-02, under 510(k) number K913749.

Who is the listed applicant for EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170?

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

What is the FDA product code for EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170?

The FDA product code for EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170 is BZQ.

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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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