Cleared Traditional

A Breathing System (ABS)

K233580 · Deepwell Dtx, Inc. · Neurology
Aug 2024
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K233580 is an FDA 510(k) clearance for the A Breathing System (ABS), a Device, Biofeedback (Class II — Special Controls, product code HCC), submitted by Deepwell Dtx, Inc. (Seattle, US). The FDA issued a Cleared decision on August 1, 2024, 268 days after receiving the submission on November 7, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5050.

Submission Details

510(k) Number K233580 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 2023
Decision Date August 01, 2024
Days to Decision 268 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HCC — Device, Biofeedback
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5050