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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name standard polysomnograph with electroencephalograph
510(k) Number K021185
Device Name NERVUS MONITOR
Applicant
TAUGAGREINING HF
PO BOX 4341
CROFTON,  MD  21114
Applicant Contact E.J. Smith
Correspondent
TAUGAGREINING HF
PO BOX 4341
CROFTON,  MD  21114
Correspondent Contact E.J. Smith
Regulation Number882.1400
Classification Product Code
OLV  
Subsequent Product Code
GWQ  
Date Received04/15/2002
Decision Date 07/12/2002
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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