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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Scintillation (Gamma)
510(k) Number K945792
Device Name IM512P
Applicant
Globus Industries
2124 Hwy. 35
Holmdel,  NJ  07733
Applicant Contact JAMES ZALAYET
Correspondent
Globus Industries
2124 Hwy. 35
Holmdel,  NJ  07733
Correspondent Contact JAMES ZALAYET
Regulation Number892.1100
Classification Product Code
IYX  
Date Received11/25/1994
Decision Date 05/24/1995
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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