NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR— 510(k) K112826
Substantially EquivalentMoor 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.. Device class: 2.
Clearance details
- Applicant
- Moor Instruments, Ltd.
- Product code
- Code MUD
- Device class
- Class 2
- Regulation
- 21 CFR 870.2700
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Axminster, Devon, GB
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- K083082 — MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS
Adverse events under product code MUD
product code MUD- Malfunction
- 467
- Total
- 467
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.