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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 K881813
Device Name CHRONODYNAMICS DATA RECORDER (CDR)-100
Applicant
Chronodynamics, Inc.
6102 N. Dixie Dr.
P.O. Box 415
Dayton,  OH  45401
Applicant Contact ALAN P SCHWARTZ
Correspondent
Chronodynamics, Inc.
6102 N. Dixie Dr.
P.O. Box 415
Dayton,  OH  45401
Correspondent Contact ALAN P SCHWARTZ
Regulation Number880.2910
Classification Product Code
FLL  
Date Received04/28/1988
Decision Date 12/05/1988
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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