KEELER SPECTRA INDIRECT OPHTHALMOSCOPE— 510(k) K970029

Name: FDA 510(k) clearance K970029
Creator: U.S. Food and Drug Administration
Published: 1997-04-02

Substantially Equivalent

Keeler Instruments, Inc.

FDA 510(k) clearance K970029 for KEELER SPECTRA INDIRECT OPHTHALMOSCOPE, Substantially Equivalent on 1997-04-02. Applicant: Keeler Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Keeler Instruments, Inc.
Product code: Code HLJ
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 1997-01-03
Decision date: 1997-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Broomall, PA, US

Download summary PDF View on FDA.gov ↗

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