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FDA 510(k) Application Details - K181709
Device Classification Name
Standard Polysomnograph With Electroencephalograph
More FDA Info for this Device
510(K) Number
K181709
Device Name
Standard Polysomnograph With Electroencephalograph
Applicant
Neurotronics, Inc.
4500 NW 27th Ave Ste C2
Gainesville, FL 32606 US
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Contact
David Pezet
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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
06/28/2018
Decision Date
11/16/2018
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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