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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name monitor, breathing frequency
510(k) Number K923402
Device Name CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR
Applicant
PRO-TECH, INC.
P.O. BOX 2165
17710-134TH AVENUE N.E.
WOODINVILLE,  WA  98072
Applicant Contact RANDY CARRUTHERS
Correspondent
PRO-TECH, INC.
P.O. BOX 2165
17710-134TH AVENUE N.E.
WOODINVILLE,  WA  98072
Correspondent Contact RANDY CARRUTHERS
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received07/10/1992
Decision Date 12/30/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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