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510(k) K123399

MYOVISION 3.0 WIREFREE SYSTEM by Precision Biometrics, Inc. — Product Code IKN

K123399 is an FDA 510(k) premarket notification submitted by Precision Biometrics, Inc. for the device "MYOVISION 3.0 WIREFREE SYSTEM". The FDA issued a decision of Substantially Equivalent on August 1, 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
August 1, 2013
Date Received
November 5, 2012
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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  • K123902 — PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S) (September 13, 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