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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Telethermographic, Infrared
510(k) Number K852950
Device Name VISITHERM
Applicant
C.D. Regelin & Associates, Inc.
4156 Library Rd.
Pittsburgh,  PA  15234
Applicant Contact COREY D REGELIN
Correspondent
C.D. Regelin & Associates, Inc.
4156 Library Rd.
Pittsburgh,  PA  15234
Correspondent Contact COREY D REGELIN
Regulation Number884.2980
Classification Product Code
IYM  
Date Received07/11/1985
Decision Date 02/07/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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