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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, High-Voltage, X-Ray, Diagnostic
510(k) Number K864624
Device Name PROBE, UPTAKE, NUCLEAR
Applicant
Carolina Medical Electronics
P. O. Box 307
King,  NC  27021
Applicant Contact JOYCE HUNSUCKER
Correspondent
Carolina Medical Electronics
P. O. Box 307
King,  NC  27021
Correspondent Contact JOYCE HUNSUCKER
Regulation Number892.1700
Classification Product Code
IZO  
Date Received11/25/1986
Decision Date 08/10/1987
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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