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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 K904397
Device Name TEC 1410
Applicant
Bay Shore Medical Equipment Corp.
Tecnomed Usa
235 S. Fehr Way
Bay Shore,  NY  11706
Applicant Contact JOHN MARCO
Correspondent
Bay Shore Medical Equipment Corp.
Tecnomed Usa
235 S. Fehr Way
Bay Shore,  NY  11706
Correspondent Contact JOHN MARCO
Regulation Number892.1700
Classification Product Code
IZO  
Date Received09/25/1990
Decision Date 11/13/1990
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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