Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model(S) 9528,9538
FDA 510(k) K071655 · Medtronic, Inc.
510(k) numberK071655
Submission
- Device name
- Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model(S) 9528,9538
- Applicant
- Medtronic, Inc.
Mounds View, MN, US - Received
- June 18, 2007
- Decision date
- November 21, 2007
- 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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|---|---|---|---|
| K243349 | BodyGuardian Remote Monitoring System (BGRMS v3.0)DSI · Traditional | Boston Scientific Cardiac Diagnostic… | 01/23/2026SE |
| K250356 | MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)DSI · Traditional | Infobionic, Inc. | 07/29/2025SE |
| K240177 | Zio AT® device (A100A1001)DSI · Traditional | iRhythm Technologies, Inc. | 10/30/2024SE |
| 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 |
| K193104 | Unified Arrhythmia Diagnostic System PocketECG IVDSI · Special | Medicalgorithmics S.A. | 04/09/2020SE |
| 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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Questions and answers
When was Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model(S) 9528,9538 cleared by the FDA?
Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model(S) 9528,9538 (K071655) received a 510(k) decision of Substantially Equivalent on November 21, 2007, 156 days after the submission was received.
What is the product code of K071655?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.