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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Diagnostic
510(k) Number K913395
Device Name EZ-1 SYSTEM RESPIRATORY EFFORT SENSORS
Applicant
Pro-Tech, Inc.
P.O. Box 2165
17710-134th Ave. NE
Woodinville,  WA  98072
Applicant Contact RANDY CARRUTHERS
Correspondent
Pro-Tech, Inc.
P.O. Box 2165
17710-134th Ave. NE
Woodinville,  WA  98072
Correspondent Contact RANDY CARRUTHERS
Regulation Number868.1840
Classification Product Code
BZG  
Date Received07/30/1991
Decision Date 05/20/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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