STANDARD

Otoscope

RUDOLF RIESTER GMBH & CO. KG

The following data is part of a premarket notification filed by Rudolf Riester Gmbh & Co. Kg with the FDA for Standard.

Pre-market Notification Details

• Device ID: K925752
• 510k Number: K925752
• Device Name: STANDARD
• Classification: Otoscope
• Applicant: RUDOLF RIESTER GMBH & CO. KG POSTFACH 35 BRUCKSTRABE 31 D-72417 Jungingen, DE
• Contact: Karlheinz Riester
• Correspondent: Karlheinz Riester; RUDOLF RIESTER GMBH & CO. KG POSTFACH 35 BRUCKSTRABE 31 D-72417 Jungingen, DE
• Product Code: ERA
• CFR Regulation Number: 874.4770 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-11-13
• Decision Date: 1993-10-08