Tempus Pro Extended Features
FDA 510(k) K133988 · Remote Diagnostic Technologies , Ltd.
510(k) numberK133988
Submission
- Device name
- Tempus Pro Extended Features
- Applicant
- Remote Diagnostic Technologies , Ltd.
Hampshire, GB - Received
- December 26, 2013
- Decision date
- May 16, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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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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 |
| K130773 | Tempus Pro Patient MonitorMWI · Traditional | 06/05/2013SE |
| 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 Extended Features cleared by the FDA?
Tempus Pro Extended Features (K133988) received a 510(k) decision of Substantially Equivalent on May 16, 2014, 141 days after the submission was received.
What is the product code of K133988?
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.