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510(k) K143507

NFANT Feeding Solution by Nfant Labs, LLC — Product Code HCC

K143507 is an FDA 510(k) premarket notification submitted by Nfant Labs, LLC for the device "NFANT Feeding Solution". The FDA issued a decision of Substantially Equivalent on September 9, 2015. 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
September 9, 2015
Date Received
December 10, 2014
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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  • K180173 — Freespira (August 23, 2018)
  • K163448 — GrindCare System (September 1, 2017)
  • K151050 — Pacifier Activated Lullaby (PAL®) (December 22, 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)
  • K073557 — EEG NEUROAMP, MODEL CS10137 (February 28, 2008)

FDA data resources