OCT-OPTHALMOSCOPE— 510(k) K042885

Name: FDA 510(k) clearance K042885
Creator: U.S. Food and Drug Administration
Published: 2005-01-21

Substantially Equivalent

Ophthalmic Technologies, Inc.

FDA 510(k) clearance K042885 for OCT-OPTHALMOSCOPE, Substantially Equivalent on 2005-01-21. Applicant: Ophthalmic Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Ophthalmic Technologies, Inc.
Product code: Code HLI
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 2004-10-19
Decision date: 2005-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hasbrouck, NJ, US

Download summary PDF View on FDA.gov ↗

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