Patient Monitor
FDA 510(k) K123711 · Shenzhen Creative Industry Co., Ltd.
510(k) numberK123711
Submission
- Device name
- Patient Monitor
- Applicant
- Shenzhen Creative Industry Co., Ltd.
Echo, AZ, US - Received
- December 4, 2012
- Decision date
- October 1, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K201468 | Pulse OximeterDQA · Traditional | 01/25/2021SE |
| K192343 | Patient MonitorDQA · Traditional | 12/31/2019SE |
| K172792 | Handheld Pulse Oximeter, Model SP-20DQA · Traditional | 11/13/2018SE |
| K170047 | All-in-One Health Monitor, PC-303MWI · Traditional | 09/09/2017SE |
| K150093 | Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E…DQA · Special | 06/03/2015SE |
| K120502 | PC-60NW Fingertip OximeterDQA · Abbreviated | 12/07/2012SE |
| K093016 | Vital Signs MonitorDQA · Traditional | 03/30/2010SE |
| K082055 | Model PC-860 Fetal DopplerKNG · Traditional | 02/06/2009SE |
| K073152 | PC-180 / Prince 180 Easy ECG MonitorDSH · Traditional | 01/10/2008SE |
| K063641 | PC-60, Non-Invasivepulse OximeterDQA · Traditional | 07/13/2007SE |
Questions and answers
When was Patient Monitor cleared by the FDA?
Patient Monitor (K123711) received a 510(k) decision of Substantially Equivalent on October 1, 2013, 301 days after the submission was received.
What is the product code of K123711?
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.