BIOINTEGRATOR, BIOINTEGRATOR PLUS— 510(k) K942769

Name: FDA 510(k) clearance K942769
Creator: U.S. Food and Drug Administration
Published: 1995-09-01

Substantially Equivalent

Bio Research Institute

FDA 510(k) clearance K942769 for BIOINTEGRATOR, BIOINTEGRATOR PLUS, Substantially Equivalent on 1995-09-01. Applicant: Bio Research Institute. Device class: 2.

Clearance details

Applicant: Bio Research Institute
Product code: Code HCC
Device class: Class 2
Regulation: 21 CFR 882.5050
Advisory panel: Neurology
Date received: 1994-06-13
Decision date: 1995-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costati, 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.