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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Ophthalmic, Ac-Powered
510(k) Number K822991
Device Name AO DOCUSTAR(MMIRO) FUNDUS CAMERA
Applicant
WARNER-LAMBERT CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
WARNER-LAMBERT CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number886.1120
Classification Product Code
HKI  
Date Received10/12/1982
Decision Date 02/24/1983
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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