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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 K040194
Device Name COMPUMEDICS SUMMIT IP
Applicant
Compumedics USA, Ltd.
7850 Paseo Del Norte
El Paso,  TX  79912
Applicant Contact ELVIRA GARCIA
Correspondent
Compumedics USA, Ltd.
7850 Paseo Del Norte
El Paso,  TX  79912
Correspondent Contact ELVIRA GARCIA
Regulation Number868.2375
Classification Product Code
MNR  
Date Received01/28/2004
Decision Date 04/23/2004
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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