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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K912742
Device Name ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE
Applicant
Spacelabs, Inc.
15220 NE 40th St.
P.O. Box 97013
Redmond,  WA  98073 -9713
Applicant Contact RAYMOND W GIFFORD
Correspondent
Spacelabs, Inc.
15220 NE 40th St.
P.O. Box 97013
Redmond,  WA  98073 -9713
Correspondent Contact RAYMOND W GIFFORD
Regulation Number880.2910
Classification Product Code
FLL  
Date Received06/21/1991
Decision Date 04/20/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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