HME · Class I · 21 CFR 886.1140

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

Leading manufacturers include American Optical Corp., Woodlyn, Inc. and Sds Dental, Inc..

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 Feb 12, 1987
STORZ ENT/OPHTHALMIC MAXI CHAIR
K870112
Storz Instrument Co.
Ophthalmic · 31d
Cleared Sep 24, 1986
-OM WEST 2000 GNATUS CHAIR
K863008
Sds Dental, Inc.
Ophthalmic · 47d
Cleared Jun 19, 1984
WOODLYN CLASSIC EXAM. CHAIR
K842045
Woodlyn, Inc.
Ophthalmic · 29d
Cleared Aug 13, 1980
A O CUSTOM II CHAIR AND STAND
K801638
American Optical Corp.
Ophthalmic · 27d

About Product Code HME - Regulatory Context