BIONAIRE CLEAR AIR AIR PURIFIER & IONIZER— 510(k) K942434

Name: FDA 510(k) clearance K942434
Creator: U.S. Food and Drug Administration
Published: 1994-12-14

Substantially Equivalent

Bionaire Corp.

FDA 510(k) clearance K942434 for BIONAIRE CLEAR AIR AIR PURIFIER & IONIZER, Substantially Equivalent on 1994-12-14. Applicant: Bionaire Corp.. Device class: 2.

Clearance details

Applicant: Bionaire Corp.
Product code: Code FRF
Device class: Class 2
Regulation: 21 CFR 880.5045
Advisory panel: General Hospital
Date received: 1994-05-20
Decision date: 1994-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lachine, Quebec, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code FRF

view all

K251872 — Biomoneta Avata Rx2025-11-14
K242102 — CerroZone Mini2024-11-19
K240696 — Airdog X8 Air Purifier (KJ800F-X8)2024-06-14
K223835 — MA-40, MA-1122023-09-18
K222416 — RIA Safeguard2023-05-01

More clearances from Bionaire Corp.

view all

K942683 — BIONAIRE HEPA AIR PURIFIERS /SH-1240, 1260, 1840, 1860, CH-35501994-11-28

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