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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thermometer, electronic, clinical
510(k) Number K964286
Device Name ZOMED PASSIVE TEMPERATURE PROBE
Applicant
ZOMED INTL.
967 NORTH SHORELINE BLVD.
MOUNTAIN VIEW,  CA  94043
Applicant Contact THOMAS C WEHMAN, PH.D.
Correspondent
ZOMED INTL.
967 NORTH SHORELINE BLVD.
MOUNTAIN VIEW,  CA  94043
Correspondent Contact THOMAS C WEHMAN, PH.D.
Regulation Number880.2910
Classification Product Code
FLL  
Date Received10/28/1996
Decision Date 11/19/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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