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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 K061764
Device Name MEDIBYTE, MODEL MP8
Applicant
Braebon Medical Corp.
120 Walgreen Dr. (Rr#3)
Suite #1
Carp, Ontario,  CA K0A 1L0
Applicant Contact RICHARD A BONATO
Correspondent
Braebon Medical Corp.
120 Walgreen Dr. (Rr#3)
Suite #1
Carp, Ontario,  CA K0A 1L0
Correspondent Contact RICHARD A BONATO
Regulation Number868.2375
Classification Product Code
MNR  
Date Received06/22/2006
Decision Date 09/06/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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