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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 K910118
Device Name DATA RECORDER
Applicant
Healthdyne, Inc.
3371 Lenora Church Rd.
Snellville,  GA  30039
Applicant Contact TIM COWART
Correspondent
Healthdyne, Inc.
3371 Lenora Church Rd.
Snellville,  GA  30039
Correspondent Contact TIM COWART
Regulation Number880.2910
Classification Product Code
FLL  
Date Received01/11/1991
Decision Date 02/14/1991
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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