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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name amplifier, physiological signal
510(k) Number K884071
Device Name AMPLAID EMG15
Applicant
AMPLUS CORP.
65 BRISTLECONE WAY
BOULDER,  CO  80304
Applicant Contact MARGARET MAZZONI
Correspondent
AMPLUS CORP.
65 BRISTLECONE WAY
BOULDER,  CO  80304
Correspondent Contact MARGARET MAZZONI
Regulation Number882.1835
Classification Product Code
GWL  
Date Received09/27/1988
Decision Date 02/27/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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