Cleared Traditional

K822991 - AO DOCUSTAR(MMIRO) FUNDUS CAMERA
(FDA 510(k) Clearance)

K822991 · Warner-Lambert Co. · Ophthalmic

Feb 1983

Decision

135d

Days

Class 2

Risk

K822991 is an FDA 510(k) clearance for the AO DOCUSTAR(MMIRO) FUNDUS CAMERA. This device is classified as a Camera, Ophthalmic, Ac-powered (Class II — Special Controls, product code HKI).

Submitted by Warner-Lambert Co. (Walker, US). The FDA issued a Cleared decision on February 24, 1983, 135 days after receiving the submission on October 12, 1982.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number	K822991 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 12, 1982
Decision Date	February 24, 1983
Days to Decision	135 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—