Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)
FDA 510(k) K071641 · Medtronic, Inc.
510(k) numberK071641
Submission
- Device name
- Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)
- Applicant
- Medtronic, Inc.
Mounds View, MN, US - Received
- June 15, 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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| 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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Questions and answers
When was Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539) cleared by the FDA?
Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539) (K071641) received a 510(k) decision of Substantially Equivalent on November 21, 2007, 159 days after the submission was received.
What is the product code of K071641?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.