KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004— 510(k) K032087

Name: FDA 510(k) clearance K032087
Creator: U.S. Food and Drug Administration
Published: 2003-11-26

Substantially Equivalent

Keeler Instruments, Inc.

FDA 510(k) clearance K032087 for KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004, Substantially Equivalent on 2003-11-26. 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: 2003-07-07
Decision date: 2003-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Broomall, PA, US

Download summary PDF View on FDA.gov ↗

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