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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 K860132
Device Name AIR CARE AIR SANITIZER
Applicant
Cooper-Hewitt Electric Co.
Arent,Fox,Kintner,Plotkin,Kahn
1050 Connecticut Ave., Nw.
Washington,  DC  20036
Applicant Contact PETER REICHERTZ
Correspondent
Cooper-Hewitt Electric Co.
Arent,Fox,Kintner,Plotkin,Kahn
1050 Connecticut Ave., Nw.
Washington,  DC  20036
Correspondent Contact PETER REICHERTZ
Regulation Number880.6500
Classification Product Code
FRA  
Date Received01/14/1986
Decision Date 01/13/1987
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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