NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL BSM-2300A SERIES

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

NIHON KOHDEN AMERICA, INC.

The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Nihon Kohden Bsm-2300a Series Bedside Monitor And Accessories, Model Bsm-2300a Series.

Pre-market Notification Details

• Device ID: K011918
• 510k Number: K011918
• Device Name: NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL BSM-2300A SERIES
• Classification: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
• Applicant: NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601
• Contact: Bonnie Bishop
• Correspondent: Bonnie Bishop; NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601
• Product Code: MHX
• CFR Regulation Number: 870.1025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-06-20
• Decision Date: 2001-09-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04931921859728	K011918	000
04931921101728	K011918	000
04931921101681	K011918	000
04931921101629	K011918	000
00841983103544	K011918	000
00841983103179	K011918	000
00841983100154	K011918	000