MODEL 6500 OPTHALMIC CHAIR— 510(k) K864494

Name: FDA 510(k) clearance K864494
Creator: U.S. Food and Drug Administration
Published: 1986-12-15

Substantially Equivalent

Koken Mfg Company, Inc.

FDA 510(k) clearance K864494 for MODEL 6500 OPTHALMIC CHAIR, Substantially Equivalent on 1986-12-15. Applicant: Koken Mfg Company, Inc.. Device class: 1.

Clearance details

Applicant: Koken Mfg Company, Inc.
Product code: Code HME
Device class: Class 1
Regulation: 21 CFR 886.1140
Advisory panel: Ophthalmic
Date received: 1986-11-14
Decision date: 1986-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HME

view all

K930449 — MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR1993-07-06
K914416 — BREATH-EASY, MODIFICATION1992-06-23
K894018 — RELIANCE(R) 6200 EXAMINATION CHAIR1989-09-12
K870112 — STORZ ENT/OPHTHALMIC MAXI CHAIR1987-02-12
K864574 — MAC 150E OPTHALMIC CHAIR1986-12-15

More clearances from Koken Mfg Company, Inc.

view all

K864501 — KOKEN'S NEW MODEL M-3000 POWER TABLE1986-12-16
K864295 — DR.500O OPERATING TABLE1986-11-19
K864325 — DR7700 OPERATING TABLE1986-11-19

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