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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name refractometer, ophthalmic
510(k) Number K861065
Device Name AR-1100 AUTOMATIC REFRACTOR
Applicant
NIDEK, INC.
2460 EMBARCADERO WAY
P.O.BOX 50488
PALO ALTO,  CA  94303
Applicant Contact JOHN BRATKOWSKY
Correspondent
NIDEK, INC.
2460 EMBARCADERO WAY
P.O.BOX 50488
PALO ALTO,  CA  94303
Correspondent Contact JOHN BRATKOWSKY
Regulation Number886.1760
Classification Product Code
HKO  
Date Received03/20/1986
Decision Date 04/09/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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