KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER— 510(k) K864037

Name: FDA 510(k) clearance K864037
Creator: U.S. Food and Drug Administration
Published: 1986-11-13

Substantially Equivalent

Kera Corp.

FDA 510(k) clearance K864037 for KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER, Substantially Equivalent on 1986-11-13. Applicant: Kera Corp.. Device class: 1.

Clearance details

Applicant: Kera Corp.
Product code: Code HJB
Device class: Class 1
Regulation: 21 CFR 886.1450
Advisory panel: Ophthalmic
Date received: 1986-10-16
Decision date: 1986-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

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K924779 — BURTON KERATOMETER - MODLE 20401993-04-05
K864369 — LTS CORNEAL MICROSCOPE LASER TOMOGRAPHIC SCANNER1986-12-15
K852424 — ACUFEX COMPARATIVE SURGICAL KERATOMETER1985-09-11

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Data sourced from openFDA. This site is unofficial and independent of the FDA.