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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 K021138
Device Name SLEEPSCREEN/APNOESCREEN CARDIO
Applicant
ERICH JAEGER GMBH
22705 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887 -4645
Applicant Contact BRIAN LONG
Correspondent
ERICH JAEGER GMBH
22705 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887 -4645
Correspondent Contact BRIAN LONG
Regulation Number868.2375
Classification Product Code
MNR  
Date Received04/09/2002
Decision Date 02/12/2003
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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