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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Purifier, Air, Ultraviolet, Medical
510(k) Number K033448
FOIA Releasable 510(k) K033448
Device Name ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER
Applicant
John Mfg., Ltd.
18780 Amar Rd., Suite 203-203
Walnut,  CA  91789
Applicant Contact ARTHUR KING MA
Correspondent
John Mfg., Ltd.
18780 Amar Rd., Suite 203-203
Walnut,  CA  91789
Correspondent Contact ARTHUR KING MA
Regulation Number880.6500
Classification Product Code
FRA  
Subsequent Product Code
FRF  
Date Received10/29/2003
Decision Date 07/12/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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