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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode, cutaneous
510(k) Number K032278
Device Name AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE
Applicant
AMBU, INC.
611 NORTH HAMMONDS FERRY RD.
LINTHICUM,  MD  21090 -1356
Applicant Contact SANJAY PARIKH
Correspondent
AMBU, INC.
611 NORTH HAMMONDS FERRY RD.
LINTHICUM,  MD  21090 -1356
Correspondent Contact SANJAY PARIKH
Regulation Number882.1320
Classification Product Code
GXY  
Date Received07/24/2003
Decision Date 03/05/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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