A Breathing System (ABS)

FDA 510(k) K233580 · Deepwell Dtx, Inc.

Substantially Equivalent

510(k) numberK233580

Submission

Device name
A Breathing System (ABS)
Applicant
Deepwell Dtx, Inc.
Seattle, WA, US
Received
November 7, 2023
Decision date
August 1, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HCC – Device, Biofeedback
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5050
Specialty
Neurology

Other 510(k)s with product code HCC

510(k)DeviceApplicantDecision
K222101PrismHCC · Traditional Graymatters Health , Ltd.03/17/2023SE
K180173FreespiraHCC · Traditional Palo Alto Health Sciences, Inc.08/23/2018SE
K163448GrindCare SystemHCC · Traditional Sunstar Suisse S.A.09/01/2017SE
K151050Pacifier Activated Lullaby (PAL®)HCC · Traditional Power Medical Devices, LLC12/22/2015SE
K143507NFANT Feeding SolutionHCC · Traditional Nfant Labs, LLC09/09/2015SE
K131586Canary Breathing SystemHCC · Traditional Palo Alto Health Sciences, Inc.12/10/2013SE
K122879EEGER4 Model 4.3HCC · Traditional Eeg Software, LLC02/06/2013SE
K111687Emg SystemHCC · Special Myotronics-Noromed, Inc.09/29/2011SE
K092675GrindcareHCC · Traditional Medotech A/S03/03/2010SE
K073557EEG Neuroamp, Model CS10137HCC · Traditional Corscience GmbH & Co. KG02/28/2008SE

Questions and answers

When was A Breathing System (ABS) cleared by the FDA?

A Breathing System (ABS) (K233580) received a 510(k) decision of Substantially Equivalent on August 1, 2024, 268 days after the submission was received.

What is the product code of K233580?

The FDA product code is HCC – Device, Biofeedback, a Class II (moderate risk) device regulated under 21 CFR 882.5050.