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510(k) K110048

CERSR ELECTROMYOGRAPHY SYSTEM by Spinematrix, Inc. — Product Code IKN

K110048 is an FDA 510(k) premarket notification submitted by Spinematrix, Inc. for the device "CERSR ELECTROMYOGRAPHY SYSTEM". The FDA issued a decision of Substantially Equivalent on January 26, 2011. The device falls under product code IKN (Electromyograph, Diagnostic), a Class II device regulated under 21 CFR 890.1375.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2011
Date Received
January 6, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electromyograph, Diagnostic
Device Class
Class II
Regulation Number
890.1375
Review Panel
NE
Submission Type

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FDA data resources