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FDA 510(k) Application Details - K984580
Device Classification Name
Standard Polysomnograph With Electroencephalograph
More FDA Info for this Device
510(K) Number
K984580
Device Name
Standard Polysomnograph With Electroencephalograph
Applicant
BIOSYS AB (PUBL)
485 LAROE RD.
CHESTER, NY 10918 US
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Contact
JANE B CAMPBELL
Other 510(k) Applications for this Contact
Regulation Number
882.1400
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Classification Product Code
OLV
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More FDA Info for this Product Code
Date Received
12/23/1998
Decision Date
03/12/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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