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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K010916
Device Name PTW DOSIMETRY DIODE, T60008
Applicant
PTW-NEW YORK CORP.
201 PARK AVE.
HICKSVILLE,  NY  11801
Applicant Contact STEPHEN R SZEGLIN
Correspondent
PTW-NEW YORK CORP.
201 PARK AVE.
HICKSVILLE,  NY  11801
Correspondent Contact STEPHEN R SZEGLIN
Regulation Number892.5050
Classification Product Code
IYE  
Date Received03/27/2001
Decision Date 06/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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