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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 K944175
Device Name ADAM SHELL THERMOCOUPLE ASSEMBLY
Applicant
Pro-Tech Services, Inc.
17710-134th Ave. NE
P.O Box 2165
Woodinville,  WA  98072
Applicant Contact RANDY CARRUTHERS
Correspondent
Pro-Tech Services, Inc.
17710-134th Ave. NE
P.O Box 2165
Woodinville,  WA  98072
Correspondent Contact RANDY CARRUTHERS
Regulation Number868.1840
Classification Product Code
BZG  
Date Received08/26/1994
Decision Date 10/14/1994
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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