Fukuda Denshi Dynascope Model DS-5000 Series Telemetry System
FDA 510(k) K980728 · Fukuda Denshi USA, Inc.
510(k) numberK980728
Submission
- Device name
- Fukuda Denshi Dynascope Model DS-5000 Series Telemetry System
- Applicant
- Fukuda Denshi USA, Inc.
Redmond, WA, US - Received
- February 25, 1998
- Decision date
- June 19, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSI – Detector And Alarm, Arrhythmia
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
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| K230265 | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemDSI · Abbreviated | Infobionic, Inc. | 10/06/2023SE |
| K231276 | SmartCardia 7L PlatformDSI · Traditional | Smartcardia SA | 08/30/2023SE |
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| K192732 | BodyGuardian Remote Monitoring SystemDSI · Traditional | Preventice Technologies, Inc. | 03/26/2020SE |
| K190574 | Patient Assistant Model PA97000DSI · Traditional | Medtronic, Inc. | 09/24/2019SE |
| K182532 | Liba3 SystemDSI · Traditional | National Cardiac, Inc. | 05/15/2019SE |
| K181658 | MobileECG 2 BTDSI · Traditional | Memtec Corporation | 03/26/2019SE |
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| 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 |
| K033711 | Fukuda Denshi Dynascope Model DS-5000 Central Telemetry SystemMHX · Special | 06/03/2004SE |
Questions and answers
When was Fukuda Denshi Dynascope Model DS-5000 Series Telemetry System cleared by the FDA?
Fukuda Denshi Dynascope Model DS-5000 Series Telemetry System (K980728) received a 510(k) decision of Substantially Equivalent on June 19, 1998, 114 days after the submission was received.
What is the product code of K980728?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.