Fukuda Denshi Dynascope Model DS-5000 Central Telemetry System
FDA 510(k) K033711 · Fukuda Denshi USA, Inc.
510(k) numberK033711
Submission
- Device name
- Fukuda Denshi Dynascope Model DS-5000 Central Telemetry System
- Applicant
- Fukuda Denshi USA, Inc.
Redmond, WA, US - Received
- November 26, 2003
- Decision date
- June 3, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
Other 510(k)s with product code MHX
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|---|---|---|---|
| K260656 | Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP…MHX · Traditional | GE Healthcare Finland Oy | 09/01/2026SE |
| K260343 | Carescape Canvas 1000; Carescape Canvas Smart DisplayMHX · Traditional | GE Healthcare Finland Oy | 08/28/2026SE |
| 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 |
| K253277 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PMHX · Traditional | Ge Medical Systems Information Technologies, Inc. | 07/24/2026SE |
| 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 |
More from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K173226 | CardiMax ElectrocardiographDPS · Traditional | 04/16/2018SE |
| K150030 | Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorMHX · Traditional | 03/16/2015SE |
| 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 |
| K083697 | Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model…MHX · Traditional | 03/19/2009SE |
| 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 |
| K040246 | Fukuda Denshi Dynascope Model DS-7141 Portable Patient MonitorMHX · Traditional | 05/26/2004SE |
Questions and answers
When was Fukuda Denshi Dynascope Model DS-5000 Central Telemetry System cleared by the FDA?
Fukuda Denshi Dynascope Model DS-5000 Central Telemetry System (K033711) received a 510(k) decision of Substantially Equivalent on June 3, 2004, 190 days after the submission was received.
What is the product code of K033711?
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.