Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model DS-7000//7000M/7210/7210M
FDA 510(k) K083697 · Fukuda Denshi USA, Inc.
510(k) numberK083697
Submission
- Device name
- Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model DS-7000//7000M/7210/7210M
- Applicant
- Fukuda Denshi USA, Inc.
Redmond, WA, US - Received
- December 15, 2008
- Decision date
- March 19, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
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| K260579 | Infinity® Acute Care System (IACS) VG8.1MHX · Traditional | Draeger Medical Systems, Inc. | 08/20/2026SE |
| K251508 | Telemetry Monitor (iT30, iT50)MHX · Traditional | Edan Instruments, Inc. | 08/06/2026SE |
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| K254209 | Radius VSM and AccessoriesMHX · Traditional | Masimo Corporation | 06/04/2026SE |
| K252840 | M12 Telemetry SystemMHX · Traditional | Global Instrumentation, LLC | 05/29/2026SE |
| K260098 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C…MHX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 05/20/2026SE |
| K250349 | Vista CMSMHX · Traditional | Shanghai Draeger Medical Instrument Co., Ltd. | 04/24/2026SE |
| K253170 | uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient MonitorsMHX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 04/16/2026SE |
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| K134046 | Fukuda Denshi Dynascope Model DS-8100N/8100M Patient MonitorMHX · Traditional | 02/12/2015SE |
| K112521 | Fukuda Denshi Vasera Model VS-1500DXN · Traditional | 12/21/2011SE |
| K103134 | Fukuda DenshiMHX · Traditional | 03/11/2011SE |
| K082656 | Model FF Sonic US-750 XT Diagnostic Ultrasound System 3D Imaging UnitIYN · Traditional | 09/30/2008SE |
| K081891 | Fukuda Denshi Dynascope Model DS-7000/7000M Patient MonitorMHX · Traditional | 08/29/2008SE |
| K050363 | Fukuda Denshi Model UF-850XTDIYN · Special | 02/17/2005SE |
| K033711 | Fukuda Denshi Dynascope Model DS-5000 Central Telemetry SystemMHX · Special | 06/03/2004SE |
| K040246 | Fukuda Denshi Dynascope Model DS-7141 Portable Patient MonitorMHX · Traditional | 05/26/2004SE |
Questions and answers
When was Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model DS-7000//7000M/7210/7210M cleared by the FDA?
Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model DS-7000//7000M/7210/7210M (K083697) received a 510(k) decision of Substantially Equivalent on March 19, 2009, 94 days after the submission was received.
What is the product code of K083697?
The FDA product code is MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.1025.