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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 K012437
Device Name DEVILBISS SLEEP RECORDER MODEL # RM60
Applicant
SUNRISE MEDICAL HHG, INC.
100 DEVILBISS DR.
SOMERSET,  PA  15501
Applicant Contact JIM FROEHLICH
Correspondent
SUNRISE MEDICAL HHG, INC.
100 DEVILBISS DR.
SOMERSET,  PA  15501
Correspondent Contact JIM FROEHLICH
Regulation Number868.2375
Classification Product Code
MNR  
Date Received07/31/2001
Decision Date 07/16/2002
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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