Modification to Acuity Central Monitoring System
FDA 510(k) K022453 · Welch Allyn Protocol, Inc.
510(k) numberK022453
Submission
- Device name
- Modification to Acuity Central Monitoring System
- Applicant
- Welch Allyn Protocol, Inc.
Beaverton, OR, US - Received
- July 26, 2002
- Decision date
- August 21, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
Other 510(k)s with product code DSI
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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 |
More from Memtec Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K070204 | Link to Acuity Clinician NotifierMSX · Special | 03/23/2007SE |
| K063419 | Modification to Vsm- Vital Signs Monitor, (VSM 300 )MWI · Special | 12/04/2006SE |
| K033378 | Vital Signs Monitor, Propaq LTMWI · Traditional | 03/01/2004SE |
| K031740 | VSM - Vital Signs Monitor, Model 53000 SeriesDQA · Traditional | 08/26/2003SE |
| K021681 | Micropaq, Models 402, 404DRT · Special | 07/23/2002SE |
| K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246DRT · Special | 08/20/2001SE |
Questions and answers
When was Modification to Acuity Central Monitoring System cleared by the FDA?
Modification to Acuity Central Monitoring System (K022453) received a 510(k) decision of Substantially Equivalent on August 21, 2002, 26 days after the submission was received.
What is the product code of K022453?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.