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510(k) K133670

HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE by Neocoil, LLC — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2014
Date Received
November 29, 2013
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Nuclear Magnetic Resonance Imaging
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type

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