LVV Option
FDA 510(k) K781855 · Honeywell, Inc.
510(k) numberK781855
Submission
- Device name
- LVV Option
- Applicant
- Honeywell, Inc.
Mchenry, IL, US - Received
- November 6, 1978
- Decision date
- January 5, 1979
- 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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|---|---|---|---|
| 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 |
|---|---|---|
| K902230 | Colorado Color Imaging RecorderDSF · Traditional | 06/19/1990SE |
| K863100 | Cen Sta Mon Ac/Dc Alarm Central Acces Alarm RecorDPS · Traditional | 02/03/1987SE |
| K853501 | Honeywell Electronic Ventilator Ev-ACBK · Traditional | 04/04/1986SE |
| K855125 | Physiological Telemetry Patient Monitoring SystemDRT · Traditional | 03/26/1986SE |
| K851888 | Apm Dispos. Blood Pressure TransducerDRS · Traditional | 08/06/1985SE |
| K851496 | ECG Monitor Model RM102DXJ · Traditional | 07/24/1985SE |
| K850794 | Patient Monitor Model RM-300DTR · Traditional | 04/18/1985SE |
| K851092 | Portable Defibrillator/Monitor Ed 425LDD · Traditional | 04/10/1985SE |
| K834530 | Extension Box EB200DRT · Traditional | 06/01/1984SE |
| K834282 | Ultra Imager 2000IYO · Traditional | 04/23/1984SE |
Questions and answers
When was LVV Option cleared by the FDA?
LVV Option (K781855) received a 510(k) decision of Substantially Equivalent on January 5, 1979, 60 days after the submission was received.
What is the product code of K781855?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.