Uni II

510(k) Number

K925756 ↗

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).

• DORC LIGHTWEIGHT BINOCULAR OPHTHALMOSCOP by JEDMED Instrument Company
• HEINE MINI 3000(R) OPHTHALMOSCOPE by Heine Optotechnik GmbH & Co. KG
• KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 by Keeler Instruments, Inc.
• FOCOMETER by Lacrimedics, Inc.
• HEINE BETA 200(R) OPHTHALMOSCOPE by Heine Optotechnik GmbH & Co. KG
• MS401097-17, MS722-K, MS720, MS721, MS722 by Alexander Mfg. Co.
• IRAS GLARE TESTER by Randwal Instrument Co., Inc.
• HALOGEN DIAGNOSTIC SET BX A - 12345 by Neitz Instruments Company, Ltd.
• EYESCOPE by Visual Methods, Inc.
• KEELER SPECTRA INDIRECT OPHTHALMOSCOPE by Keeler Instruments, Inc.

• 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 →