K233580
- 510(k) number
- K233580
- Device name
- A Breathing System (ABS)
- Applicant
- Deepwell Dtx, Inc. WA · US
- Product code
- HCC — Device, Biofeedback
- Decision date
- 2024-08-01
- Date received
- 2023-11-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.7 MB · U.S. public domain
Also available from FDA: K233580.pdf
Official FDA record: K233580
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.