HCC

Device, Biofeedback

Product code: HCC
Device name: Device, Biofeedback
Device class: Class 2
21 CFR: 21 CFR 882.5050
Medical specialty: Neurology
Marketing pathway: 510(K) Exempt
510(k) clearances (last 3 years): 1
Summaries archived here: 1 (direct download)
510(k) clearances (all years, FDA): 172 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-08-01.

Number	Decision date	Applicant	Device name	Summary
K233580	2024-08-01	Deepwell Dtx, Inc.	A Breathing System (ABS)	PDF

1 summaries are archived here for direct download.

Official FDA classification page: HCC

Classification and pathway per current FDA publications. Data from openFDA (CC0).