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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleaner, Air, Medical Recirculating
510(k) Number K942683
Device Name BIONAIRE HEPA AIR PURIFIERS /SH-1240, 1260, 1840, 1860, CH-3550
Applicant
Bionaire Corp.
2000-32nd Ave.
Lachine H8t 3h7,  CA
Applicant Contact PAUL CROWHURST
Correspondent
Bionaire Corp.
2000-32nd Ave.
Lachine H8t 3h7,  CA
Correspondent Contact PAUL CROWHURST
Regulation Number880.5045
Classification Product Code
FRF  
Date Received06/07/1994
Decision Date 11/28/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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