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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chair, Ophthalmic, Ac-Powered
510(k) Number K914416
Device Name BREATH-EASY, MODIFICATION
Applicant
Icor AB
Ulvsundavagen 178 B
Bromma,  SE 161 30
Applicant Contact ANDRAS GEDEON
Correspondent
Icor AB
Ulvsundavagen 178 B
Bromma,  SE 161 30
Correspondent Contact ANDRAS GEDEON
Regulation Number886.1140
Classification Product Code
HME  
Date Received09/25/1991
Decision Date 06/23/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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