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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 K013905
Device Name MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS
Applicant
Pro-Tech Services, Inc.
4338 Harbour Pt.e Blvd. SW
Mukilteo,  WA  98275
Applicant Contact NEIL SHELLER
Correspondent
Pro-Tech Services, Inc.
4338 Harbour Pt.e Blvd. SW
Mukilteo,  WA  98275
Correspondent Contact NEIL SHELLER
Regulation Number868.2375
Classification Product Code
MNR  
Date Received11/26/2001
Decision Date 04/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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