FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M

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-7000 Series Patient Monitor, Model Ds-7000//7000m/7210/7210m.

Pre-market Notification Details

• Device ID: K083697
• 510k Number: K083697
• Device Name: FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M
• Classification: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
• Applicant: FUKUDA DENSHI USA, INC. 17725 N.E. 65TH ST., BLDG. C Redmond, WA 98052 -4911
• Contact: Doug Blakely
• Correspondent: Doug Blakely; FUKUDA DENSHI USA, INC. 17725 N.E. 65TH ST., BLDG. C Redmond, WA 98052 -4911
• Product Code: MHX
• Subsequent Product Code: BZQ
• Subsequent Product Code: CCK
• Subsequent Product Code: DQA
• Subsequent Product Code: DRT
• Subsequent Product Code: DSK
• Subsequent Product Code: DXN
• Subsequent Product Code: FFL
• CFR Regulation Number: 870.1025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-12-15
• Decision Date: 2009-03-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04538612226656	K083697	000
04538612014710	K083697	000
04538612039515	K083697	000
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04538612914676	K083697	000
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04538612911460	K083697	000
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04538612913433	K083697	000
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04538612903595	K083697	000
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04538612911354	K083697	000
04538612913440	K083697	000