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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 K111742
Device Name MDRIVE
Applicant
EMBLA SYSTEMS
9351 GRANT STREET
SUITE 600
THORNTON,  CO  80229
Applicant Contact ROBERT G SCHUEPPERT
Correspondent
EMBLA SYSTEMS
9351 GRANT STREET
SUITE 600
THORNTON,  CO  80229
Correspondent Contact ROBERT G SCHUEPPERT
Regulation Number868.2375
Classification Product Code
MNR  
Date Received06/21/2011
Decision Date 08/31/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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