CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR— 510(k) K082853

Name: FDA 510(k) clearance K082853
Creator: U.S. Food and Drug Administration
Published: 2009-03-23

Substantially Equivalent

Inspired Technologies, Inc.

FDA 510(k) clearance K082853 for CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR, Substantially Equivalent on 2009-03-23. Applicant: Inspired Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Inspired Technologies, Inc.
Product code: Code MNR
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2008-09-29
Decision date: 2009-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, US

Download summary PDF View on FDA.gov ↗

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