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510(k) K233580

A Breathing System (ABS) by Deepwell Dtx, Inc. — Product Code HCC

K233580 is an FDA 510(k) premarket notification submitted by Deepwell Dtx, Inc. for the device "A Breathing System (ABS)". The FDA issued a decision of Substantially Equivalent on August 1, 2024. 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
August 1, 2024
Date Received
November 7, 2023
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 for product code HCC

  • 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)
  • K073557 — EEG NEUROAMP, MODEL CS10137 (February 28, 2008)

FDA data resources