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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full-Montage Standard Electroencephalograph
510(k) Number K040554
FOIA Releasable 510(k) K040554
Device Name ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM71256
Applicant
MANUFACTURING TECHNOLOGY, INC.
70 READY AVE., N.W.
FORT WALTON BEACH,  FL  32548
Applicant Contact JOHN G SCHNEIDER
Correspondent
MANUFACTURING TECHNOLOGY, INC.
70 READY AVE., N.W.
FORT WALTON BEACH,  FL  32548
Correspondent Contact JOHN G SCHNEIDER
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received03/02/2004
Decision Date 07/16/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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