510(k) K201746 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Tempus Pro Patient Monitor
| Applicant | Remote Diagnostic Technologies Limited, Basingstoke, GB |
| Decision | Substantially Equivalent, Sep 18, 2020 |
| Received | Jun 26, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K201746
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 8, 2026 | Remote Diagnostic Technologies Ltd. Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R.
USB 2-Channel IBP Module, REF: 01-2017.
Used with User/Operator Manual Open, Classified |
MHX | None listed |
| Jul 25, 2025 | Remote Diagnostic Technologies Ltd. Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The kit is an accessory to the Tempus Pro Monitor, REF: 00-1007-R, 00-1024-R, 00-1026-R Open, Classified |
MHX | None listed |
| May 7, 2025 | Remote Diagnostic Technologies Ltd. Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R,
00-1026-R, 00-1004, 00-1007 Open, Classified |
MHX | None listed |
| Apr 24, 2025 | Remote Diagnostic Technologies Ltd. Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer) Open, Classified |
MHX | None listed |
| Sep 21, 2023 | Remote Diagnostic Technologies Ltd. Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007, when Used With Tempus Pro Video Laryngoscope, REF 01-2044 Open, Classified |
MHX | None listed |
| Apr 1, 2023 | Remote Diagnostic Technologies Ltd. Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital Open, Classified |
MHX | None listed |
| May 25, 2021 | Remote Diagnostic Technologies Ltd. Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm.
Part No. - 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. Product Usage: intended to be used as a stand-alone monitor or as a t Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.