Ambulatory (Holter) Recording System - Modified
FDA 510(k) K895266 · Biosensor Corp.
510(k) numberK895266
Submission
- Device name
- Ambulatory (Holter) Recording System - Modified
- Applicant
- Biosensor Corp.
Minneapolis, MN, US - Received
- August 23, 1989
- Decision date
- January 26, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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|---|---|---|---|
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| 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 |
More from Memtec Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K990956 | Biosensor Holter Monitor System Software, Model 1005DQK · Traditional | 06/14/1999SE |
| K974546 | Biosensor Holter Monitor SystemDQK · Traditional | 03/04/1998SE |
| K974192 | Biosensor Holter Monitor SystemDQK · Traditional | 03/04/1998SE |
| K950944 | Ambulatory (Holter) Recording SystemDQK · Traditional | 06/18/1996SE |
| K960449 | PC ECG 1200 ECG and Stress Electrocardiography Testing System(Version 2.90)DPS · Traditional | 05/30/1996SE |
| K943338 | Biosensor Bidop Vascular Test SystemJAF · Traditional | 04/12/1996SE |
| K950723 | Ambulatory (Holter) Recording SystemDQK · Traditional | 02/09/1996SE |
| K922027 | Ambulatory (Holter) Recording, ModificationDSI · Traditional | 02/17/1993SE |
| K831676 | Biosensor Asc SystemDSI · Traditional | 12/01/1983SE |
Questions and answers
When was Ambulatory (Holter) Recording System - Modified cleared by the FDA?
Ambulatory (Holter) Recording System - Modified (K895266) received a 510(k) decision of Substantially Equivalent on January 26, 1990, 156 days after the submission was received.
What is the product code of K895266?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.