BIOLOGICAL SOUND MONITOR (BSM) SENSOR— 510(k) K021389

Name: FDA 510(k) clearance K021389
Creator: U.S. Food and Drug Administration
Published: 2002-10-01

Substantially Equivalent

Andromed, Inc.

FDA 510(k) clearance K021389 for BIOLOGICAL SOUND MONITOR (BSM) SENSOR, Substantially Equivalent on 2002-10-01. Applicant: Andromed, Inc.. Device class: 2.

Clearance details

Applicant: Andromed, Inc.
Product code: Code DQD
Device class: Class 2
Regulation: 21 CFR 870.1875
Advisory panel: Cardiovascular
Date received: 2002-05-02
Decision date: 2002-10-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Saint Laurent, Quebec, CA

Download summary PDF View on FDA.gov ↗

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