THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE— 510(k) K854244

Name: FDA 510(k) clearance K854244
Creator: U.S. Food and Drug Administration
Published: 1985-11-12

Substantially Equivalent

Keeler Instruments, Inc.

FDA 510(k) clearance K854244 for THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE, Substantially Equivalent on 1985-11-12. 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: 1985-10-21
Decision date: 1985-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Broomall, PA, US

Download summary PDF View on FDA.gov ↗

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