HLJ · Class II · 21 CFR 886.1570

FDA Product Code HLJ: Ophthalmoscope, Battery-powered

Leading manufacturers include Rudolf Riester GmbH & Co. KG, Neitz Instruments Company, Ltd. and Heine Optotechnik GmbH & Co. KG.

47
Total
47
Cleared
123d
Avg days
1976
Since
47 devices
25–47 of 47
Cleared Feb 22, 1994
REPLACEMENT BATTERIES PART NO. 5098,5135, 5097
K936018
R & D Batteries, Inc.
Ophthalmic · 68d
Cleared Feb 22, 1994
R & D BATTERIES
K936104
R & D Batteries, Inc.
Ophthalmic · 62d
Cleared Dec 03, 1993
DE LUXE
K925755
Rudolf Riester GmbH & Co. KG
Ophthalmic · 385d
Cleared Oct 18, 1993
UNI II
K925756
Rudolf Riester GmbH & Co. KG
Ophthalmic · 339d
Cleared Oct 15, 1993
RI-FORMER
K932504
Rudolf Riester GmbH & Co. KG
Ophthalmic · 147d
Cleared Aug 03, 1993
OPHTHALMOSCOPE
K925757
Rudolf Riester GmbH & Co. KG
Ophthalmic · 263d
Cleared Mar 29, 1993
MIS
K923543
Ceram Optec, Inc.
Ophthalmic · 256d
Cleared Sep 30, 1992
MEDICAL BATTERY PACKS
K922910
Access / God Loves You
Ophthalmic · 224d
Cleared Jul 09, 1992
ORIEL
K920272
Truphatek, Ltd.
Ophthalmic · 169d
Cleared Nov 27, 1989
D.L. SCOPE OPHTHALMOSCOPE
K896072
North American Medical Products, Inc.
Ophthalmic · 39d
Cleared Nov 24, 1987
IRAS GLARE TESTER
K873987
Randwal Instrument Co., Inc.
Ophthalmic · 56d
Cleared Jun 03, 1987
VOROSCOPE(TM)
K871735
Australian Biomedical Corporation , Ltd.
Ophthalmic · 29d
Cleared Oct 04, 1985
INDIRECT OPHTHALMOSCOPE
K853891
Carl Zeiss, Inc.
Ophthalmic · 15d
Cleared Aug 16, 1983
MEDIC LUX DIAGNOSTIC SETS
K832437
Keeler Instruments, Inc.
Ophthalmic · 22d
Cleared Mar 09, 1983
DORC LIGHTWEIGHT BINOCULAR OPHTHALMOSCOP
K830215
Jedmed Instrument Co.
Ophthalmic · 44d
Cleared Oct 15, 1976
SOLA COMMIDO LOUPE
K760770
Codman & Shurtleff, Inc.
Ophthalmic · 11d
Cleared Oct 15, 1976
SOLA SCHULTZE-CROCK OPTHALMOSCOPE
K760771
Codman & Shurtleff, Inc.
Ophthalmic · 11d