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510(k) K123902

PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S) by Oktx, LLC — Product Code IKN

K123902 is an FDA 510(k) premarket notification submitted by Oktx, LLC for the device "PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)". The FDA issued a decision of Substantially Equivalent on September 13, 2013. 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
September 13, 2013
Date Received
December 18, 2012
Clearance Type
Traditional
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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  • K142494 — ViMove (May 28, 2015)
  • K131094 — VIMOVE (July 11, 2014)
  • K123399 — MYOVISION 3.0 WIREFREE SYSTEM (August 1, 2013)
  • K113074 — CMAP PRO (February 2, 2012)
  • K102610 — FOCUS EMG DEVICE (March 4, 2011)
  • K110048 — CERSR ELECTROMYOGRAPHY SYSTEM (January 26, 2011)
  • K083679 — UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1 (September 11, 2009)

FDA data resources