Tempus Pro Patient Monitor
FDA 510(k) K130773 · Remote Diagnostic Technologies , Ltd.
510(k) numberK130773
Submission
- Device name
- Tempus Pro Patient Monitor
- Applicant
- Remote Diagnostic Technologies , Ltd.
Hampshire, GB - Received
- March 20, 2013
- Decision date
- June 5, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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
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|---|---|---|---|
| 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 |
|---|---|---|
| K201746 | Tempus Pro Patient MonitorMHX · Special | 09/18/2020SE |
| K173768 | Tempus Pro Patient MonitorMHX · Special | 01/10/2018SE |
| K170567 | Tempus Pro Patient MonitorMHX · Traditional | 07/06/2017SE |
| K133973 | Tempus Pro with Enhanced FeaturesQYW · Abbreviated | 08/14/2014SE |
| K134014 | Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe)MWI · Traditional | 08/12/2014SE |
| K133988 | Tempus Pro Extended FeaturesMWI · Abbreviated | 05/16/2014SE |
| K113105 | Tempusic Patient MonitorMWI · Abbreviated | 12/15/2011SE |
| K101264 | Tempus Ic Professional Patient MonitorMWI · Traditional | 05/11/2010SE |
| K082718 | Tempusic Patient MonitorDXH · Traditional | 10/10/2008SE |
| K033410 | Tempus 2000 Patient Monitor, Model 00-0002DXH · Traditional | 03/05/2004SE |
Questions and answers
When was Tempus Pro Patient Monitor cleared by the FDA?
Tempus Pro Patient Monitor (K130773) received a 510(k) decision of Substantially Equivalent on June 5, 2013, 77 days after the submission was received.
What is the product code of K130773?
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.