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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
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