RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM— 510(k) K011238

Name: FDA 510(k) clearance K011238
Creator: U.S. Food and Drug Administration
Published: 2002-01-08

Substantially Equivalent

Metracor Technologies, Inc.

FDA 510(k) clearance K011238 for RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM, Substantially Equivalent on 2002-01-08. Applicant: Metracor Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Metracor Technologies, Inc.
Product code: Code LZF
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2001-04-23
Decision date: 2002-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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