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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 Pt.e Blvd. SW
Mukilteo,  WA  98275
Applicant Contact NEIL SHELLER
Correspondent
Tuv America, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
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
Predetermined Change
Control Plan Authorized		 No
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