Uni I

510(k) Number

K925759 ↗

FDA product code

ERA

Device class

Class I

Regulation

21 CFR Part 874.4770

Advisory committee

Ear, Nose, Throat

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 ERA (Otoscope).

• HOME CARE EAR EXAMINATIO KIT by Home Care Instruments, Inc.
• WALL CHARGER, MODEL #79111 by Welch Allyn, Inc.
• OTOSCOPE, DIAG. MODELS 20100 & 20200 by Welch Allyn, Inc.
• FAMILY EAR SCOPE MODEL 29001S by Ear Care of So. Ca., Inc.
• XOMED-TREACE ALPHASCOPE by Xomed-Treace, Inc.
• D.L. SCOPE(R) OTOSCOPE by North American Medical Products, Inc.
• AURAL-CAM, VIDEO EAR, VID RX by Gracefully Yours, Inc.
• MINI3000 F.O. LED OTOSCOPE 2,5 V D-008.70.106 by Heine Optotechnik GmbH & Co. KG
• INSPETOSCOPE by Terayco Intl., Ltd.
• STARKEY LABORATORIES OTOSCOPE by Starkey Laboratories 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 →