SPECTACLE INDIRECT OPHTHALMOSCOPE— 510(k) K841292

Name: FDA 510(k) clearance K841292
Creator: U.S. Food and Drug Administration
Published: 1984-05-09

Substantially Equivalent

Keller Instruments, Inc.

FDA 510(k) clearance K841292 for SPECTACLE INDIRECT OPHTHALMOSCOPE, Substantially Equivalent on 1984-05-09. Applicant: Keller Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Keller Instruments, Inc.
Product code: Code HLJ
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 1984-03-29
Decision date: 1984-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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