510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864494Substantially Equivalent

Model 6500 Opthalmic Chair

Koken Mfg Company, Inc., St. Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864494 is the FDA 510(k) clearance record for MODEL 6500 OPTHALMIC CHAIR, a class I device, cleared for Koken Mfg Company, Inc. on under FDA product code HME (Chair, Ophthalmic, Ac-Powered). FDA records list 5 510(k) clearances for Koken Mfg Company, Inc., from to . As of , FDA records show no recalls naming K864494.

Clearance record

Decision date
Received
(31 days to decision)
Product code
HME Chair, Ophthalmic, Ac-Powered
Regulation
21 CFR 886.1140
Device class
Class I
Review panel
Ophthalmic
Applicant
Koken Mfg Company, Inc. P.O. Box 265, St. Louis MO
Third party review
No

Clearances, product code HME

Trailing 12 months

FDA records hold no clearances under product code HME in the trailing twelve months.

FDA records show no clearances under product code HME in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HME, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260