AUTOMATED OPHTHALMICS SOFTIPS— 510(k) K992998

Name: FDA 510(k) clearance K992998
Creator: U.S. Food and Drug Administration
Published: 2000-01-10

Substantially Equivalent

Automated Ophthalmics, Inc.

FDA 510(k) clearance K992998 for AUTOMATED OPHTHALMICS SOFTIPS, Substantially Equivalent on 2000-01-10. Applicant: Automated Ophthalmics, Inc.. Device class: 2.

Clearance details

Applicant: Automated Ophthalmics, Inc.
Product code: Code HKY
Device class: Class 2
Regulation: 21 CFR 886.1930
Advisory panel: Ophthalmic
Date received: 1999-09-07
Decision date: 2000-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ellicott City, MD, US

Download summary PDF View on FDA.gov ↗

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