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510(k) K151600

R-40 EEG Amplifier by Lifelines , Ltd. — Product Code GWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2015
Date Received
June 12, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amplifier, Physiological Signal
Device Class
Class II
Regulation Number
882.1835
Review Panel
NE
Submission Type

Other clearances by Lifelines , Ltd.

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