BIOCOMP 2001 BIOFEEDBACK DEVICE— 510(k) K872495

Name: FDA 510(k) clearance K872495
Creator: U.S. Food and Drug Administration
Published: 1987-08-04

Substantially Equivalent

Biofeedback Research Institute, Inc.

FDA 510(k) clearance K872495 for BIOCOMP 2001 BIOFEEDBACK DEVICE, Substantially Equivalent on 1987-08-04. Applicant: Biofeedback Research Institute, Inc.. Device class: 2.

Clearance details

Applicant: Biofeedback Research Institute, Inc.
Product code: Code HCC
Device class: Class 2
Regulation: 21 CFR 882.5050
Advisory panel: Neurology
Date received: 1987-06-24
Decision date: 1987-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HCC

view all

K233580 — A Breathing System (ABS)2024-08-01
K222101 — Prism2023-03-17
K180173 — Freespira2018-08-23
K163448 — GrindCare System2017-09-01
K151050 — Pacifier Activated Lullaby (PAL®)2015-12-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.