Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor

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

Fukuda Denshi USA, Inc.

The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Fukuda Denshi Dynascope Model Ds-8000 Series Patient Monitor.

Pre-market Notification Details

• Device ID: K150030
• 510k Number: K150030
• Device Name: Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor
• Classification: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
• Applicant: Fukuda Denshi USA, Inc. 17725 NE 65th St, Building C Redmond, WA 98052
• Contact: Doug Blakely
• Correspondent: Doug Blakely; Fukuda Denshi USA, Inc. 17725 NE 65th St, Building C Redmond, WA 98052
• Product Code: MHX
• CFR Regulation Number: 870.1025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-01-08
• Decision Date: 2015-03-16
• Summary: summary

NIH GUDID Devices

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