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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmoscope, Ac-Powered
510(k) Number K110205
Device Name AAIO-7, AAIO WIRLESS
Applicant
Appasamy Associates
20, Sbi Officers Colony
1st St.
Arumbakkam, Chennai,  IN 600 106
Applicant Contact K RENGASAMY
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607
Correspondent Contact MARC M MOUSER
Regulation Number886.1570
Classification Product Code
HLI  
Subsequent Product Code
HLJ  
Date Received01/25/2011
Decision Date 02/09/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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