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510(k) K071866

NTRAINER SYSTEM by Kcbiomedix, Inc. — Product Code HCC

K071866 is an FDA 510(k) premarket notification submitted by Kcbiomedix, Inc. for the device "NTRAINER SYSTEM". The FDA issued a decision of Substantially Equivalent on February 1, 2008. 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 1, 2008
Date Received
July 6, 2007
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)
  • K122879 — EEGER4 MODEL 4.3 (February 6, 2013)
  • K111687 — EMG SYSTEM (September 29, 2011)
  • K092675 — GRINDCARE (March 3, 2010)

FDA data resources