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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 K033402
Device Name PORTABLE SLEEP DATA RECORDER (PSDR)
Applicant
PRO-TECH SERVICES, INC.
4338 HARBOUR POINTE BLVD. S.W.
MUKILTEO,  WA  98275
Applicant Contact NEIL SHELLER
Correspondent
TUV AMERICA, INC.
1775 OLD HIGHWAY 8
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact LAURA DANIELSON
Regulation Number868.2375
Classification Product Code
MNR  
Date Received10/24/2003
Decision Date 06/30/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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