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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Uptake, Nuclear
510(k) Number K924586
Device Name CAPTUS 500 WELL DETECTOR W/CLINICAL LABOR SOFTWARE
Applicant
Capintec Instruments, Inc.
540 Alpha Dr.
Pittsburgh,  PA  15238
Applicant Contact ANNE DELL
Correspondent
Capintec Instruments, Inc.
540 Alpha Dr.
Pittsburgh,  PA  15238
Correspondent Contact ANNE DELL
Regulation Number892.1320
Classification Product Code
IZD  
Date Received09/10/1992
Decision Date 12/03/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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