MACULAR FUNCTION ANALYZER

K843227 · Danek Medical, Inc. · HOQ · Jul 22, 1985 · Ophthalmic

Device Facts

Record IDK843227
Device NameMACULAR FUNCTION ANALYZER
ApplicantDanek Medical, Inc.
Product CodeHOQ · Ophthalmic
Decision DateJul 22, 1985
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 886.1330
Device ClassClass 1

Regulatory Classification

Identification

An Amsler grid is a device that is a series of charts with grids of different sizes that are held at 30 centimeters distance from the patient and intended to rapidly detect central and paracentral irregularities in the visual field.

Innolitics

Panel 1

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