EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170— 510(k) K913749

Name: FDA 510(k) clearance K913749
Creator: U.S. Food and Drug Administration
Published: 1992-07-02

Substantially Equivalent

Edentec Corp.

FDA 510(k) clearance K913749 for EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170, Substantially Equivalent on 1992-07-02. Applicant: Edentec Corp.. Device class: 2.

Clearance details

Applicant: Edentec Corp.
Product code: Code BZQ
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 1991-08-21
Decision date: 1992-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

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