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510(k) K011983

INSIGHT GENESIS by Fasstech — Product Code HCC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2001
Date Received
June 26, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Biofeedback
Device Class
Class II
Regulation Number
882.5050
Review Panel
NE
Submission Type

Other clearances by Fasstech

  • K063447 — INSIGHT DISCOVERY (August 16, 2007)
  • K033452 — CWAS 1000 (November 28, 2003)
  • K023209 — INSIGHT MILLENNIUM III (October 10, 2003)
  • K011964 — INSIGHT MILLENNIUM PLUS (September 20, 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)

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  • K131586 — CANARY BREATHING SYSTEM (December 10, 2013)
  • K122879 — EEGER4 MODEL 4.3 (February 6, 2013)
  • K111687 — EMG SYSTEM (September 29, 2011)
  • K092675 — GRINDCARE (March 3, 2010)