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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 K896959
Device Name RADIO-TEMP THERMOMETER
Applicant
Babymed Intl., Inc.
5680 Greenwood Plz. Blvd.#
500
Englewood,  CO  80111
Applicant Contact RICHARD ROSENBAUM
Correspondent
Babymed Intl., Inc.
5680 Greenwood Plz. Blvd.#
500
Englewood,  CO  80111
Correspondent Contact RICHARD ROSENBAUM
Regulation Number880.2910
Classification Product Code
FLL  
Date Received12/14/1989
Decision Date 03/06/1990
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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