Atlas FDA

Tempus Pro Patient Monitor

FDA 510(k) clearance K201746 · decided 2020-09-18

Clearance details

K-number
K201746
Device name
Tempus Pro Patient Monitor
Applicant
Remote Diagnostic Technologies Limited
Decision
Substantially Equivalent
Date received
2020-06-26
Decision date
2020-09-18
Days to decision
84 days
Clearance type
Special
Product code
MHX
Device class
2
Regulation number
870.1025
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Basingstoke, GB
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R recall (Z-1027-2026)Remote Diagnostic Technologies Ltd.2026-01-08
Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Num recall (Z-2175-2025)Remote Diagnostic Technologies Ltd.2025-07-25
Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-10 recall (Z-1729-2025)Remote Diagnostic Technologies Ltd.2025-05-07
Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset recall (Z-1666-2025)Remote Diagnostic Technologies Ltd.2025-04-24
Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-10 recall (Z-2625-2023)Remote Diagnostic Technologies Ltd.2023-09-21
Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinic recall (Z-1321-2023)Remote Diagnostic Technologies Ltd.2023-04-01