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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Flotation Therapy, Powered
510(k) Number K923977
Device Name AKROTECH 4000
Applicant
Lumex, Inc.
100 Spence St.
Bay Shore,  NY  11706
Applicant Contact JOSEPH MUELLER
Correspondent
Lumex, Inc.
100 Spence St.
Bay Shore,  NY  11706
Correspondent Contact JOSEPH MUELLER
Regulation Number890.5170
Classification Product Code
IOQ  
Date Received08/07/1992
Decision Date 02/12/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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