Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System

Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

Nihon Kohden Corporation

The following data is part of a premarket notification filed by Nihon Kohden Corporation with the FDA for Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System.

Pre-market Notification Details

• Device ID: K203435
• 510k Number: K203435
• Device Name: Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System
• Classification: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
• Applicant: Nihon Kohden Corporation 1-31-4 Nishiochiai, Shinjuku-Ku Tokyo, JP 161-8560
• Contact: Sandra Gadeyne
• Correspondent: Sandra Gadeyne; Nihon Kohden America 15353 Barranca Pkwy Irvine, CA 92618
• Product Code: MHX
• CFR Regulation Number: 870.1025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-11-23
• Decision Date: 2021-07-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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