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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 K942580
Device Name NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES
Applicant
Neoprobe Corp.
425 Metro Pl. N.
Suite 400
Dublin,  OH  43017
Applicant Contact SUSAN D TIEDY-STEVENSON
Correspondent
Neoprobe Corp.
425 Metro Pl. N.
Suite 400
Dublin,  OH  43017
Correspondent Contact SUSAN D TIEDY-STEVENSON
Regulation Number892.1320
Classification Product Code
IZD  
Date Received05/31/1994
Decision Date 02/09/1995
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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