CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A 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 Central Telemetry System, Model Wep-4200a Series.

Pre-market Notification Details

• Device ID: K040395
• 510k Number: K040395
• Device Name: CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES
• Classification: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
• Applicant: NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601
• Contact: Serrah Namini
• Correspondent: Serrah Namini; 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: 2004-02-17
• Decision Date: 2004-06-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04931921115145	K040395	000
04931921114957	K040395	000
00841983102967	K040395	000
00841983101458	K040395	000