TEMPUS PRO PATIENT MONITOR— 510(k) K130773
Substantially EquivalentRemote Diagnostic Technologies , Ltd.
FDA 510(k) clearance K130773 for TEMPUS PRO PATIENT MONITOR, Substantially Equivalent on 2013-06-05. Applicant: Remote Diagnostic Technologies , Ltd.. Device class: 2.
Clearance details
- Applicant
- Remote Diagnostic Technologies , Ltd.
- Product code
- Code MWI
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hampshire, GB
Recent devices under product code MWI
view allMore clearances from Remote Diagnostic Technologies , Ltd.
view allAdverse events under product code MWI
product code MWI- Death
- 16
- Malfunction
- 963
- Total
- 979
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 K130773
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130773.
Data sourced from openFDA. This site is unofficial and independent of the FDA.