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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Photokeratoscope
510(k) Number K842128
Device Name AMERICAN MEDICAL OPTICS PHOTOKERATO
Applicant
AMERICAN MEDICAL OPTICS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
AMERICAN MEDICAL OPTICS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number886.1350
Classification Product Code
HJA  
Date Received05/29/1984
Decision Date 08/07/1984
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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