LD-Oxi system
FDA 510(k) K160956 · Ld Technology, LLC
510(k) numberK160956
Submission
- Device name
- LD-Oxi system
- Applicant
- Ld Technology, LLC
Miami, FL, US - Received
- April 5, 2016
- Decision date
- July 6, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
Other 510(k)s with product code MWI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260438 | Vital Signs Monitor (CLEO2)MWI · Traditional | Infinium Medical, Inc. | 08/14/2026SE |
| K253417 | Masimo Root Monitoring SystemMWI · Traditional | Masimo Corporation | 08/12/2026SE |
| K253196 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)MWI · Traditional | Midmark Corporation | 06/12/2026SE |
| K253436 | c-med0 alphaMWI · Traditional | Cosinuss GmbH | 04/30/2026SE |
| K250135 | WAVE Clinical Platform (2.0.000)MWI · Traditional | Baxter Healthcare Corp/ Excel Medical | 01/16/2026SE |
| K241766 | QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)MWI · Traditional | Fysicon BV | 08/27/2025SE |
| K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalMWI · Traditional | Empatica S.r.l. | 06/06/2025SE |
| K241958 | WARD-CSS (v1.2.x)MWI · Traditional | Ward 24/7 Aps | 02/14/2025SE |
| K243146 | iCare APPMWI · Traditional | Ihealth Labs, Inc. | 02/03/2025SE |
| K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)MWI · Traditional | Welch Allyn, Inc. | 12/20/2024SE |
More from Welch Allyn, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K200287 | BP-BT KioskDXN · Traditional | 05/15/2020SE |
| K200141 | Oxi-W SystemMWI · Special | 04/27/2020SE |
| K173696 | TBL-ABI SystemJOM · Special | 12/19/2017SE |
| K152216 | SudoCGZO · Special | 09/24/2015SE |
| K143152 | TM-ABI systemJOM · Traditional | 07/22/2015SE |
| K140412 | ANS1 SoftwareDXN · Special | 05/22/2014SE |
| K131568 | Sudo PathGZO · Special | 06/28/2013SE |
| K130056 | Patient MonitorMWI · Traditional | 04/11/2013SE |
| K113264 | Electro Sensor Complex Software (Es Complex Software)DXN · Traditional | 03/02/2012SE |
| K103026 | Electro Sensor -Body CompositionMNW · Traditional | 03/29/2011SE |
Questions and answers
When was LD-Oxi system cleared by the FDA?
LD-Oxi system (K160956) received a 510(k) decision of Substantially Equivalent on July 6, 2016, 92 days after the submission was received.
What is the product code of K160956?
The FDA product code is MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.2300.