KOWA HAND-HELD APPLANATION TONOMETER HA-1— 510(k) K960924

Name: FDA 510(k) clearance K960924
Creator: U.S. Food and Drug Administration
Published: 1996-06-04

Substantially Equivalent

Kowa Optimed, Inc.

FDA 510(k) clearance K960924 for KOWA HAND-HELD APPLANATION TONOMETER HA-1, Substantially Equivalent on 1996-06-04. Applicant: Kowa Optimed, Inc.. Device class: 2.

Clearance details

Applicant: Kowa Optimed, Inc.
Product code: Code HKY
Device class: Class 2
Regulation: 21 CFR 886.1930
Advisory panel: Ophthalmic
Date received: 1996-03-06
Decision date: 1996-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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K954780 — KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C1995-12-01
K954781 — KOWA GENESIS HAND-HELD FUNDUS CAMERA1995-12-01

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