AAIO-7, AAIO WIRLESS


Device Classification Name

ophthalmoscope, ac-powered

510(k) Number K110205
Device Name AAIO-7, AAIO WIRLESS
Applicant
APPASAMY ASSOCIATES
20, sbi officers colony
1st street
arumbakkam, chennai, 

IN

600 106

Applicant Contact k rengasamy
Regulation Number 886.1570
Classification Product Code
HLI  
Subsequent Product Code
HLJ  
Date Received 01/25/2011
Decision Date 02/09/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Neurology

statement

statement

Type Traditional
Reviewed by Third Party Yes

Combination Product

No