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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 K061705
Device Name CADWELL EASYNET NASAL PRESSURE MODULE
Applicant
CADWELL LABORATORIES, INC.
909 NORTH KELLOGG ST.
KENNEWICK,  WA  99336
Applicant Contact CHRIS BOLKAN
Correspondent
CADWELL LABORATORIES, INC.
909 NORTH KELLOGG ST.
KENNEWICK,  WA  99336
Correspondent Contact CHRIS BOLKAN
Regulation Number868.2375
Classification Product Code
MNR  
Date Received06/16/2006
Decision Date 11/21/2006
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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