DIGITAL RETINOSCOPIC PHOTOMETER— 510(k) K951179

Name: FDA 510(k) clearance K951179
Creator: U.S. Food and Drug Administration
Published: 1995-05-30

Substantially Equivalent

Kudi Kalu, Inc.

FDA 510(k) clearance K951179 for DIGITAL RETINOSCOPIC PHOTOMETER, Substantially Equivalent on 1995-05-30. Applicant: Kudi Kalu, Inc.. Device class: 1.

Clearance details

Applicant: Kudi Kalu, Inc.
Product code: Code HKO
Device class: Class 1
Regulation: 21 CFR 886.1760
Advisory panel: Ophthalmic
Date received: 1995-03-16
Decision date: 1995-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntsville, AL, US

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