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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 K963597
FOIA Releasable 510(k) K963597
Device Name SILENT NIGHT I
Applicant
Local Silence, Inc.
935 Fremont Ave., Suite 115
Los Altos,  CA  94024
Applicant Contact TONY MATOUK
Correspondent
Local Silence, Inc.
935 Fremont Ave., Suite 115
Los Altos,  CA  94024
Correspondent Contact TONY MATOUK
Regulation Number868.2375
Classification Product Code
MNR  
Date Received09/09/1996
Decision Date 01/23/1997
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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