Nihon Kohden CSM 1901 Bedside Monitor

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

Nihon Kohden

The following data is part of a premarket notification filed by Nihon Kohden with the FDA for Nihon Kohden Csm 1901 Bedside Monitor.

Pre-market Notification Details

• Device ID: K151080
• 510k Number: K151080
• Device Name: Nihon Kohden CSM 1901 Bedside Monitor
• Classification: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
• Applicant: Nihon Kohden 15353 Barranca Parkway Irvine, CA 92618
• Contact: Tom Bento
• Correspondent: Al Pacheco; CERTIFIED COMPLIANCE SOLUTIONS, INC. 11665 AVENA PLACE, SUITE 203 San Diego, CA 92128
• Product Code: MHX
• CFR Regulation Number: 870.1025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-04-22
• Decision Date: 2015-11-05
• Summary: summary

NIH GUDID Devices

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