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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 K033534
Device Name VITALSENSE
Applicant
Mini-Mitter Co., Inc.
20300 Empire Ave. Bldg. B-3
Bend,  OR  97701
Applicant Contact JACK E MCKENZIE
Correspondent
Mini-Mitter Co., Inc.
20300 Empire Ave. Bldg. B-3
Bend,  OR  97701
Correspondent Contact JACK E MCKENZIE
Regulation Number880.2910
Classification Product Code
FLL  
Date Received11/10/2003
Decision Date 04/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Expedited Review Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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