DeviceClearance

Tempus Pro Patient Monitor— 510(k) K201746

Substantially Equivalent

Remote Diagnostic Technologies Limited

FDA 510(k) clearance K201746 for Tempus Pro Patient Monitor, Substantially Equivalent on 2020-09-18. Applicant: Remote Diagnostic Technologies Limited. Device class: 2.

Clearance details

Applicant
Remote Diagnostic Technologies Limited
Product code
Code MHX
Device class
Class 2
Regulation
21 CFR 870.1025
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Basingstoke, GB
Download summary PDFView on FDA.gov ↗

Recent devices under product code MHX

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Adverse events under product code MHX

product code MHX
Death
580
Injury
2,441
Malfunction
12,655
Other
3
Total
15,679

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K201746

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K201746.

Data sourced from openFDA. This site is unofficial and independent of the FDA.