BIG BEN

System, Measurement, Blood-pressure, Non-invasive

RUD RIESTER GMBH & CO KG

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

Pre-market Notification Details

• Device ID: K942650
• 510k Number: K942650
• Device Name: BIG BEN
• Classification: System, Measurement, Blood-pressure, Non-invasive
• Applicant: RUD RIESTER GMBH & CO KG BRUCKSTR.31,P.O.BOX 35 Jungingen, DE
• Contact: Karlheinz Riester
• Correspondent: Karlheinz Riester; RUD RIESTER GMBH & CO KG BRUCKSTR.31,P.O.BOX 35 Jungingen, DE
• Product Code: DXN
• CFR Regulation Number: 870.1130 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-05-31
• Decision Date: 1994-08-15