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510(k) K090811

INSPIRA HD, MODEL: NL1000 by Neurologica Corporation — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2009
Date Received
March 25, 2009
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Tomography, Computed, Emission
Device Class
Class II
Regulation Number
892.1200
Review Panel
RA
Submission Type

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