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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 NORTH TORREY PINES CT.
SUITE 100
LA JOLLA,  CA  92037
Applicant Contact STEVE REITZLER
Correspondent
COMPUMEDICS PTD LTD.
3377 NORTH 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
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