HLJ · Class II · 21 CFR 886.1570

FDA Product Code HLJ: Ophthalmoscope, Battery-powered

Leading manufacturers include Keeler Instruments, Inc., R & D Batteries, Inc. and Codman & Shurtleff, Inc..

47
Total
47
Cleared
123d
Avg days
1976
Since

FDA 510(k) Cleared Ophthalmoscope, Battery-powered Devices (Product Code HLJ)

47 devices
1–24 of 47
Cleared Nov 26, 2003
KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004
K032087
Keeler Instruments, Inc.
Ophthalmic · 142d
Cleared Apr 02, 1997
KEELER SPECTRA INDIRECT OPHTHALMOSCOPE
K970029
Keeler Instruments, Inc.
Ophthalmic · 89d
Cleared Jun 03, 1994
R&D BATTERIES, PART NOS. 5135, 5097, 5444, AND 5502
K942034
R & D Batteries, Inc.
Ophthalmic · 36d
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 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

About Product Code HLJ - Regulatory Context