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510(k) K113074

CMAP PRO by Medical Technologies, Inc. — Product Code IKN

K113074 is an FDA 510(k) premarket notification submitted by Medical Technologies, Inc. for the device "CMAP PRO". The FDA issued a decision of Substantially Equivalent on February 2, 2012. 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
February 2, 2012
Date Received
October 17, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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)
  • K123902 — PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S) (September 13, 2013)
  • K123399 — MYOVISION 3.0 WIREFREE SYSTEM (August 1, 2013)
  • 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