Agilent Component Monitoring System, Agilent Cardiac Output Module, Agilent Invasive Pressure Module, Model M1175A/76A
FDA 510(k) K002758 · Agilent Technologies Deutschland GmbH
510(k) numberK002758
Submission
- Device name
- Agilent Component Monitoring System, Agilent Cardiac Output Module, Agilent Invasive Pressure Module, Model M1175A/76A
- Applicant
- Agilent Technologies Deutschland GmbH
Boeblingen,, DE - Received
- September 5, 2000
- Decision date
- February 22, 2001
- 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
Other 510(k)s with product code DSI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K003038 | Agilent Component Monitoring System, Agilent V24/26, Agilent Bis Module, Model…OLW · Traditional | 12/15/2000SE |
| K001722 | Agilent Component Monitoring System; Agilent Invasive Blood Pressure ModuleMHX · Special | 06/30/2000SE |
| K001333 | Agilent Component Monitoring System, Agilent Multi-Measurement Server and Compact…DSI · Special | 05/17/2000SE |
Questions and answers
When was Agilent Component Monitoring System, Agilent Cardiac Output Module, Agilent Invasive Pressure Module, Model M1175A/76A cleared by the FDA?
Agilent Component Monitoring System, Agilent Cardiac Output Module, Agilent Invasive Pressure Module, Model M1175A/76A (K002758) received a 510(k) decision of Substantially Equivalent on February 22, 2001, 170 days after the submission was received.
What is the product code of K002758?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.