Sfa Module
FDA 510(k) K896528 · Life Sciences Manufacturing, Inc.
510(k) numberK896528
Submission
- Device name
- Sfa Module
- Applicant
- Life Sciences Manufacturing, Inc.
West Lebanon, NH, US - Received
- November 16, 1989
- Decision date
- January 26, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXG – Computer, Diagnostic, Pre-Programmed, Single-Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1435
- Specialty
- Cardiovascular
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| K251275 | VitalStream ART Connect; VitalStream-HemoDXG · Traditional | Caretaker Medical | 09/26/2025SE |
| K232048 | Cogent Hemodynamic Monitoring System; Cogent HMSDXG · Traditional | Icu Medical | 12/20/2023SE |
| K212529 | Hypotension Decision Assist Model HDA-OR2DXG · Special | Directed Systems, Ltd. | 11/23/2021SE |
| K192169 | PulsioFlex Monitoring System with ProAQT SensorDXG · Traditional | Pulsion Medical Systems SE | 04/30/2020SE |
| K193179 | EV1000 Clinical PlatformDXG · Special | Edwards Lifesciences, LLC | 12/17/2019SE |
| K190955 | Hypotension Decision AssistDXG · Traditional | Directed Systems, Ltd. | 11/27/2019SE |
| K181372 | ArgosDXG · Traditional | Retia Medical, LLC | 12/13/2018SE |
| K172259 | PulsioFlex Monitoring SystemDXG · Traditional | Pulsion Medical Systems SE | 01/18/2018SE |
| K163334 | LiDCOunity v2 Hemodynamic MonitorDXG · Traditional | Lidco, Ltd. | 06/05/2017SE |
More from Lidco, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K910905 | Sfa-Ii Microprocessor-Controlled ModuleDRQ · Traditional | 07/24/1991SE |
| K903700 | Ipg-Ii ModuleDSB · Traditional | 01/16/1991SE |
| K900365 | Pag Microprocessor-Controlled ModuleDQC · Traditional | 07/18/1990SE |
| K896500 | Cwd/Ppg ModuleJOM · Traditional | 07/18/1990SE |
| K895588 | Portable Air PlethysmographDSB · Traditional | 03/27/1990SE |
| K884624 | Mvl/Modulab with PVR ModuleJOM · Traditional | 02/01/1989SE |
| K873041 | A-V RecorderDPT · Traditional | 02/04/1988SE |
| K832679 | Non-Invasive Clinical Vascular LabDQC · Traditional | 01/03/1984SE |
| K822522 | Cutaneous Pressure PlethysmographDSB · Traditional | 09/28/1982SE |
| K811560 | Automated Physiologic Profile MonitorDXG · Traditional | 06/18/1981SE |
Questions and answers
When was Sfa Module cleared by the FDA?
Sfa Module (K896528) received a 510(k) decision of Substantially Equivalent on January 26, 1990, 71 days after the submission was received.
What is the product code of K896528?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.