Ophthalmoscope

510(k) Number

K925757 ↗

FDA product code

HLJ

Device class

Class II

Regulation

21 CFR Part 886.1570

Advisory committee

Ophthalmic

FDA decision

SESE Substantially Equivalent

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code HLJ (Ophthalmoscope, Battery-Powered).

• NEITZ HALOGEN OPHTHALMOSCOPE BXA-13 by Neitz Instruments Company, Ltd.
• HEINE SIGMA®250 000 C-008.33.320 by Heine Optotechnik GmbH & Co. KG
• HEINE SIGMA 250 & HEINE SIGMA 250 M2 by Heine Optotechnik GmbH & Co. KG
• OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS by American Diagnostic Corporation
• R & D BATTERIES by R & D BATTERIES, INC.
• MIS by Ceram Optec, Inc.
• 66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A by Suzhou 66 Vision-Tech Co., Ltd.
• R&D BATTERIES, PART NOS. 5135, 5097, 5444, AND 5502 by R & D BATTERIES, INC.
• OPTYSE OPHTHALMOSCOPE by Ophthalmos, Ltd.
• MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT by Magna Fortis Corporation

• Stethoscope duplex® 2.0 white, 4210-02

  Class I

  FDA 510(k) K944337 Active Cleared 30 Nov 1994 GUDID on market

• Velcro cuff 1 tube, adults, 107.005

  Class II

  FDA 510(k) K942777 Active Cleared 27 Jul 1994 GUDID on market

• schiötz C tonometer, inclined scale, silver 5112

  Class II

  FDA 510(k) K945541 Active Cleared 8 May 1995 GUDID on market

• schiötz B tonometer, inclined scale, silver 5111

  Class II

  FDA 510(k) K945541 Active Cleared 8 May 1995 GUDID on market

See all devices from Rudolf Riester GmbH & Co. KG →