Witt Biomedical VX-80
FDA 510(k) K880258 · Witt Biomedical Corporation
510(k) numberK880258
Submission
- Device name
- Witt Biomedical VX-80
- Applicant
- Witt Biomedical Corporation
Indian Harbour Bch, FL, US - Received
- January 22, 1988
- Decision date
- June 16, 1988
- 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
Other 510(k)s with product code DXG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253092 | Argos Infinity (Rev. 1.0)DXG · Traditional | Retia Medical Systems, Inc. | 02/13/2026SE |
| 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 |
|---|---|---|
| K101571 | Xper Information Management and Flex Cardio Physiomonitoring SystemsMWI · Traditional | 10/26/2010SE |
| K063840 | Xper Information Management/Physiomonitoring 5 System And/Or Vascular 5, Patient Care…MWI · Traditional | 02/06/2007SE |
| K063547 | Calysto Series IV Physio-Monitoring and Information SystemMWI · Special | 12/21/2006SE |
| K040195 | Calysto Image Iv-Image and Information Management SystemLLZ · Traditional | 04/07/2004SE |
| K033030 | Calysto Series IV Patient Care Monitors and Central Station and ECG Management SystemMWI · Traditional | 02/24/2004SE |
| K010058 | Image IV Dicom Image Archival Pacs NetworkLLZ · Traditional | 03/21/2001SE |
| K973474 | Witt Biomedical Central Station Monitoring System and Witt Biomedical Advanced Patient…MHX · Traditional | 03/13/1998SE |
| K950436 | Witt Biomedical Series IVMHX · Traditional | 11/02/1995SE |
| K945582 | Witt Biomedical Image IIILLZ · Traditional | 06/19/1995SE |
| K923054 | Witt Biomedical Series Ii-EpMHX · Traditional | 02/25/1993SE |
Questions and answers
When was Witt Biomedical VX-80 cleared by the FDA?
Witt Biomedical VX-80 (K880258) received a 510(k) decision of Substantially Equivalent on June 16, 1988, 146 days after the submission was received.
What is the product code of K880258?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.