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510(k) K063447

INSIGHT DISCOVERY by Fasstech — Product Code IKN

K063447 is an FDA 510(k) premarket notification submitted by Fasstech for the device "INSIGHT DISCOVERY". The FDA issued a decision of Substantially Equivalent on August 16, 2007. The device falls under product code IKN (Electromyograph, Diagnostic), a Class II device regulated under 21 CFR 890.1375. Fasstech has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2007
Date Received
November 15, 2006
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

Other clearances by Fasstech

  • K033452 — CWAS 1000 (November 28, 2003)
  • K023209 — INSIGHT MILLENNIUM III (October 10, 2003)
  • K011964 — INSIGHT MILLENNIUM PLUS (September 20, 2001)
  • K011983 — INSIGHT GENESIS (August 30, 2001)
  • K990778 — INSIGHT MILLENNIUM (June 3, 1999)
  • K961212 — SPINAL TOUCH (June 12, 1996)
  • K940050 — FOCUS EMG (February 24, 1995)
  • K925197 — PSI 220 DUAL EMG (February 2, 1993)

Other clearances for product code IKN

  • K172743 — Natus VikingQuest (December 19, 2017)
  • K163150 — ViMove2 (July 14, 2017)
  • K162383 — Cadwell Sierra Summit, Cadwell Sierra Ascent (March 1, 2017)
  • 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)
  • K113074 — CMAP PRO (February 2, 2012)
  • K102610 — FOCUS EMG DEVICE (March 4, 2011)
  • K110048 — CERSR ELECTROMYOGRAPHY SYSTEM (January 26, 2011)

FDA data resources