BIONAIRE HEPA AIR PURIFIERS /SH-1240, 1260, 1840, 1860, CH-3550— 510(k) K942683

Name: FDA 510(k) clearance K942683
Creator: U.S. Food and Drug Administration
Published: 1994-11-28

Substantially Equivalent

Bionaire Corp.

FDA 510(k) clearance K942683 for BIONAIRE HEPA AIR PURIFIERS /SH-1240, 1260, 1840, 1860, CH-3550, Substantially Equivalent on 1994-11-28. 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: 1994-06-07
Decision date: 1994-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lachine H8t 3h7, CA

Download summary PDF View on FDA.gov ↗

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