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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 K940014
Device Name PLM SENSOR, MODEL PLM1
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 Number868.2375
Classification Product Code
BZQ  
Date Received01/04/1994
Decision Date 11/10/1994
Decision SE SUBJECT TO TRACKING REG (ST)
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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