HME · Class I · 21 CFR 886.1140

FDA Product Code HME: Chair, Ophthalmic, Ac-powered

Leading manufacturers include F. & F. Koenigkramer, Koken Mfg Company, Inc. and Icor AB.

16
Total
16
Cleared
67d
Avg days
1978
Since

FDA 510(k) Cleared Chair, Ophthalmic, Ac-powered Devices (Product Code HME)

16 devices
1–16 of 16
Cleared Jul 06, 1993
MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR
K930449
Marco Ophthalmic, Inc.
Ophthalmic · 161d
Cleared Jun 23, 1992
BREATH-EASY, MODIFICATION
K914416
Icor AB
Ophthalmic · 272d
Cleared Sep 12, 1989
RELIANCE(R) 6200 EXAMINATION CHAIR
K894018
Reliance Medical Products, Inc.
Ophthalmic · 98d
Cleared Feb 12, 1987
STORZ ENT/OPHTHALMIC MAXI CHAIR
K870112
Storz Instrument Co.
Ophthalmic · 31d
Cleared Dec 15, 1986
MODEL 6500 OPTHALMIC CHAIR
K864494
Koken Mfg Company, Inc.
Ophthalmic · 31d
Cleared Dec 15, 1986
MAC 150E OPTHALMIC CHAIR
K864574
Koken Mfg Company, Inc.
Ophthalmic · 25d
Cleared Oct 31, 1986
THE ERGOSYSTEM CHAIR
K863728
Charles D. Bell, Inc.
Ophthalmic · 38d
Cleared Sep 24, 1986
-OM WEST 2000 GNATUS CHAIR
K863008
Sds Dental, Inc.
Ophthalmic · 47d
Cleared Oct 17, 1985
TECHNA VISION, INC. ELECTRIC CHAIR
K853743
Techna Vision
Ophthalmic · 41d
Cleared Sep 05, 1985
RELIANCE 1000, RELIANCE 1500, RELIANCE 2000
K853149
F. & F. Koenigkramer
Ophthalmic · 38d
Cleared Sep 05, 1985
RELIANCE 6100
K853150
F. & F. Koenigkramer
Ophthalmic · 38d
Cleared Sep 05, 1985
RELIANCE 5000
K853151
F. & F. Koenigkramer
Ophthalmic · 38d
Cleared Jun 19, 1984
WOODLYN CLASSIC EXAM. CHAIR
K842045
Woodlyn, Inc.
Ophthalmic · 29d
Cleared Mar 05, 1984
DOWING OPHTHALMIC CHAIR AC-POWERED
K833539
Vision Health Technology
Ophthalmic · 152d
Cleared Aug 13, 1980
A O CUSTOM II CHAIR AND STAND
K801638
American Optical Corp.
Ophthalmic · 27d
Cleared Nov 03, 1978
MAXI-CHAIR
K781801
Surgical Mechanical Research, Inc.
Ophthalmic · 11d

About Product Code HME - Regulatory Context