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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 Dr.
Bonita Springs,  FL  34134
Applicant Contact PAUL DRYDEN
Correspondent
Inspired Technologies, Inc.
24301 Woodsage Dr.
Bonita Springs,  FL  34134
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
Predetermined Change
Control Plan Authorized		 No
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