NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR— 510(k) K112826

Substantially Equivalent

Moor Instruments, Ltd.

FDA 510(k) clearance K112826 for NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR, Substantially Equivalent on 2012-10-10. Applicant: Moor Instruments, Ltd..

Clearance details

Applicant: Moor Instruments, Ltd.
Product code: Code MUD
Advisory panel: Cardiovascular
Date received: 2011-09-28
Decision date: 2012-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Axminster, Devon, GB

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Adverse events under product code MUD

product code MUD

Malfunction: 467
Total: 467

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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