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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Lesion, Radiofrequency
510(k) Number K052878
Device Name NT-1000
Applicant
Neuro Therm, Inc.
2 Debush Ave. Bldg. A2
Middleton,  MA  01949
Applicant Contact WILLIAM RITTMAN
Correspondent
Neuro Therm, Inc.
2 Debush Ave. Bldg. A2
Middleton,  MA  01949
Correspondent Contact WILLIAM RITTMAN
Regulation Number882.4400
Classification Product Code
GXD  
Date Received10/12/2005
Decision Date 01/23/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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