Masimo O3 Regional Oximeter System— 510(k) K182429
Substantially EquivalentMasimo Corporation
FDA 510(k) clearance K182429 for Masimo O3 Regional Oximeter System, Substantially Equivalent on 2019-06-07. Applicant: Masimo Corporation.
Clearance details
- Applicant
- Masimo Corporation
- Product code
- Code MUD
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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.