Bioma 2000
FDA 510(k) K862808 · E.B.S., Inc.
510(k) numberK862808
Submission
- Device name
- Bioma 2000
- Applicant
- E.B.S., Inc.
Canada, CA - Received
- July 23, 1986
- Decision date
- February 19, 1987
- 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 |
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Questions and answers
When was Bioma 2000 cleared by the FDA?
Bioma 2000 (K862808) received a 510(k) decision of Substantially Equivalent on February 19, 1987, 211 days after the submission was received.
What is the product code of K862808?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.