Bomed-Nccom
FDA 510(k) K813020 · Bomed Medical Mfr., Ltd.
510(k) numberK813020
Submission
- Device name
- Bomed-Nccom
- Applicant
- Bomed Medical Mfr., Ltd.
Mchenry, IL, US - Received
- October 27, 1981
- Decision date
- December 14, 1981
- 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 |
|---|---|---|
| K853706 | Bomed-CdmDSB · Traditional | 04/14/1986SE |
| K853705 | Bomed-EeaDRX · Traditional | 01/13/1986SE |
| K831422 | BioflowDSB · Traditional | 09/12/1983SE |
| K831421 | Bomed BioconDSB · Traditional | 09/12/1983SE |
| K830792 | Pulsette 110 Transcutaneous Elec-NerveGZJ · Traditional | 03/29/1983SE |
| K811999 | Bo Med BiaDSB · Traditional | 08/31/1981SE |
| K810064 | Pulsarii, High Volt. Galvanic Musc. StimIPF · Traditional | 01/26/1981SE |
Questions and answers
When was Bomed-Nccom cleared by the FDA?
Bomed-Nccom (K813020) received a 510(k) decision of Substantially Equivalent on December 14, 1981, 48 days after the submission was received.
What is the product code of K813020?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.