VANTAGE INDIRECT OPHTHALMOSCOPE— 510(k) K060822

Name: FDA 510(k) clearance K060822
Creator: U.S. Food and Drug Administration
Published: 2006-05-23

Substantially Equivalent

Keeler Instruments, Inc.

FDA 510(k) clearance K060822 for VANTAGE INDIRECT OPHTHALMOSCOPE, Substantially Equivalent on 2006-05-23. Applicant: Keeler Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Keeler Instruments, Inc.
Product code: Code HLI
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 2006-03-27
Decision date: 2006-05-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Broomall, PA, US

Download summary PDF View on FDA.gov ↗

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