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510(k) K122879

EEGER4 MODEL 4.3 by Eeg Software, LLC — Product Code HCC

K122879 is an FDA 510(k) premarket notification submitted by Eeg Software, LLC for the device "EEGER4 MODEL 4.3". The FDA issued a decision of Substantially Equivalent on February 6, 2013. The device falls under product code HCC (Device, Biofeedback), a Class II device regulated under 21 CFR 882.5050.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2013
Date Received
September 19, 2012
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

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  • 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)
  • K111687 — EMG SYSTEM (September 29, 2011)
  • K092675 — GRINDCARE (March 3, 2010)
  • K073557 — EEG NEUROAMP, MODEL CS10137 (February 28, 2008)

FDA data resources