Ri-Scope (S)

510(k) Number

K932506 ↗

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).

• OTO-BRITE HANDLE by JEDMED Instrument Company
• CONPHAR OTOSCOPE by Conphar, Inc.
• REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLE by National Custom Ent., Inc.
• VIDEO OTOSCOPE by Cuda Products Co.
• WELCH ALLYN BI-OTOSCOPE by Welch Allyn, Inc.
• OPTIEAR by Nankivell Industries, Inc.
• VIDEOTOSCOPE by Welch Allyn, Inc.
• LANTOS 3D EAR SCANNER by Lantos Technologies
• PEDIA PALS by Pedia Pals, Inc.
• CONPHAR OTOSCOPE/OPTHALMASCOPE by Conphar, 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 →