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510(k) K011964

INSIGHT MILLENNIUM PLUS by Fasstech — Product Code HCC

K011964 is an FDA 510(k) premarket notification submitted by Fasstech for the device "INSIGHT MILLENNIUM PLUS". The FDA issued a decision of Substantially Equivalent on September 20, 2001. The device falls under product code HCC (Device, Biofeedback), a Class II device regulated under 21 CFR 882.5050. Fasstech has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2001
Date Received
June 25, 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)
  • 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 HCC

  • K233580 — A Breathing System (ABS) (August 1, 2024)
  • K222101 — Prism (March 17, 2023)
  • K180173 — Freespira (August 23, 2018)
  • K163448 — GrindCare System (September 1, 2017)
  • K151050 — Pacifier Activated Lullaby (PAL®) (December 22, 2015)
  • K143507 — NFANT Feeding Solution (September 9, 2015)
  • 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)

FDA data resources