Masimo Rad-97 Pulse CO-Oximeter and Accessories— 510(k) K193626
Substantially EquivalentMasimo Corporation
FDA 510(k) clearance K193626 for Masimo Rad-97 Pulse CO-Oximeter and Accessories, Substantially Equivalent on 2020-08-10. Applicant: Masimo Corporation.
Clearance details
- Applicant
- Masimo Corporation
- Product code
- Code MWI
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.