ANDROFLOW - RESPIRATORY RATE MONITOR— 510(k) K051779

Name: FDA 510(k) clearance K051779
Creator: U.S. Food and Drug Administration
Published: 2005-09-30

Substantially Equivalent

Andromed, Inc.

FDA 510(k) clearance K051779 for ANDROFLOW - RESPIRATORY RATE MONITOR, Substantially Equivalent on 2005-09-30. Applicant: Andromed, Inc.. Device class: 2.

Clearance details

Applicant: Andromed, Inc.
Product code: Code BZQ
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2005-07-01
Decision date: 2005-09-30
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Saint Laurent, Quebec, CA

Download summary PDF View on FDA.gov ↗

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