Tempus 2000 Patient Monitor, Model 00-0001; Tempus Monitoring Station, Model 01-0011
FDA 510(k) K010436 · Remote Diagnostic Technologies , Ltd.
510(k) numberK010436
Submission
- Device name
- Tempus 2000 Patient Monitor, Model 00-0001; Tempus Monitoring Station, Model 01-0011
- Applicant
- Remote Diagnostic Technologies , Ltd.
Basingstoke, Hampshire, GB - Received
- February 13, 2001
- Decision date
- May 14, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXH – Transmitters And Receivers, Electrocardiograph, Telephone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2920
- Specialty
- Cardiovascular
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More from AliveCor, 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 |
| 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 |
Questions and answers
When was Tempus 2000 Patient Monitor, Model 00-0001; Tempus Monitoring Station, Model 01-0011 cleared by the FDA?
Tempus 2000 Patient Monitor, Model 00-0001; Tempus Monitoring Station, Model 01-0011 (K010436) received a 510(k) decision of Substantially Equivalent on May 14, 2001, 90 days after the submission was received.
What is the product code of K010436?
The FDA product code is DXH – Transmitters And Receivers, Electrocardiograph, Telephone, a Class II (moderate risk) device regulated under 21 CFR 870.2920.