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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 K955841
Device Name SLEEP SYSTEM FOR CLINICS & RESEARCH
Applicant
Compumedics Ptd , Ltd.
3377 N. Torrey Pines Ct.
Suite 100
La Jolla,  CA  92037
Applicant Contact STEVE REITZLER
Correspondent
Compumedics Ptd , Ltd.
3377 N. Torrey Pines Ct.
Suite 100
La Jolla,  CA  92037
Correspondent Contact STEVE REITZLER
Regulation Number868.2375
Classification Product Code
MNR  
Date Received12/22/1995
Decision Date 03/11/1997
Decision Substantially Equivalent - Kit (SESK)
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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