Handheld Monitor
FDA 510(k) K131762 · Guangdong Biolight Meditech Co., Ltd.
510(k) numberK131762
Submission
- Device name
- Handheld Monitor
- Applicant
- Guangdong Biolight Meditech Co., Ltd.
Shanghai, CN - Received
- June 17, 2013
- Decision date
- June 6, 2014
- 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 |
|---|---|---|
| K181919 | Patient MonitorMWI · Traditional | 04/05/2019SE |
| K170514 | Central Monitoring SystemMHX · Traditional | 05/24/2017SE |
| K162234 | Truscope Ultra Patient MonitorMWI · Special | 01/04/2017SE |
| K160349 | Electronic SphygmomanometerDXN · Traditional | 11/03/2016SE |
| K153580 | Central Monitoring SystemHGM · Traditional | 09/07/2016SE |
| K153135 | Vital Signs MonitorMWI · Special | 02/25/2016SE |
| K152739 | Electronic ThermometerFLL · Traditional | 02/09/2016SE |
| K151287 | Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DDQA · Traditional | 01/06/2016SE |
| K131858 | Digital ElectrocardiographDPS · Traditional | 06/11/2014SE |
| K131941 | Fetal MonitorsHGM · Traditional | 05/15/2014SE |
Questions and answers
When was Handheld Monitor cleared by the FDA?
Handheld Monitor (K131762) received a 510(k) decision of Substantially Equivalent on June 6, 2014, 354 days after the submission was received.
What is the product code of K131762?
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.