PRECISA

System, Measurement, Blood-pressure, Non-invasive

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 Precisa.

Pre-market Notification Details

• Device ID: K925294
• 510k Number: K925294
• Device Name: PRECISA
• Classification: System, Measurement, Blood-pressure, Non-invasive
• 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: DXN
• CFR Regulation Number: 870.1130 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-10-21
• Decision Date: 1994-02-23