IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM— 510(k) K854330

Name: FDA 510(k) clearance K854330
Creator: U.S. Food and Drug Administration
Published: 1985-12-13

Substantially Equivalent

Par Technology Park

FDA 510(k) clearance K854330 for IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM, Substantially Equivalent on 1985-12-13. Applicant: Par Technology Park. Device class: 2.

Clearance details

Applicant: Par Technology Park
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 1985-10-28
Decision date: 1985-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Hartford, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.