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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, electrical, evoked response
510(k) Number K093304
Device Name PROTEKTOR 32
Applicant
NATUS MEDICAL, INC.
2568 BRISTOL CIRCLE
OAKVILLE, ONTARIO,  CA L6H 5S1
Applicant Contact GOLDY SINGH
Correspondent
NATUS MEDICAL, INC.
2568 BRISTOL CIRCLE
OAKVILLE, ONTARIO,  CA L6H 5S1
Correspondent Contact GOLDY SINGH
Regulation Number882.1870
Classification Product Code
GWF  
Subsequent Product Codes
GWE   GWJ   OLT  
Date Received10/21/2009
Decision Date 08/11/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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