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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilatory Effort Recorder
510(k) Number K082853
Device Name CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR
Applicant
INSPIRED TECHNOLOGIES, INC.
24301 WOODSAGE DRIVE
BONITA SPRINGS,  FL  34134 -2958
Applicant Contact PAUL DRYDEN
Correspondent
INSPIRED TECHNOLOGIES, INC.
24301 WOODSAGE DRIVE
BONITA SPRINGS,  FL  34134 -2958
Correspondent Contact PAUL DRYDEN
Regulation Number868.2375
Classification Product Code
MNR  
Date Received09/29/2008
Decision Date 03/23/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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