Patient Monitor, Model PM50
FDA 510(k) K101127 · Contec Medical System Co., Ltd.
510(k) numberK101127
Submission
- Device name
- Patient Monitor, Model PM50
- Applicant
- Contec Medical System Co., Ltd.
Zhong Shan, Shanghai, CN - Received
- April 22, 2010
- Decision date
- June 11, 2010
- 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
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| 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 |
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| 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 |
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| K101273 | Dynamic ECG System Model TLC5000MLO · Traditional | 09/30/2011SE |
| K110156 | Ambulatory Bllod Pressure Monitor, Electronic Sphygmomanometer,DXN · Traditional | 07/27/2011SE |
| K101692 | Patient MonitorMHX · Traditional | 06/28/2011SE |
| K110774 | Electronic SphygmomanometerDXN · Traditional | 05/13/2011SE |
| K090936 | Single-Channel Handheld Electrocardiograph, Model ECG80ADPS · Traditional | 08/25/2009SE |
| K090671 | Pulse Oximeter, Models CMS50E, CMS50F, CMS60C, CMS60DDQA · Traditional | 06/11/2009SE |
| K082480 | Contec Pocket Fetal DopplerKNG · Traditional | 02/25/2009SE |
| K082641 | Fingertip Pulse Oximeter, Models CMS-50D, CMS-50L, CMS-50DLDQA · Special | 11/10/2008SE |
Questions and answers
When was Patient Monitor, Model PM50 cleared by the FDA?
Patient Monitor, Model PM50 (K101127) received a 510(k) decision of Substantially Equivalent on June 11, 2010, 50 days after the submission was received.
What is the product code of K101127?
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.