Masimo Stork— 510(k) K234021
Substantially EquivalentMasimo Corporation
FDA 510(k) clearance K234021 for Masimo Stork, Substantially Equivalent on 2024-05-03. Applicant: Masimo Corporation. Device class: 2.
Clearance details
- Applicant
- Masimo Corporation
- Product code
- Code QYU
- Device class
- Class 2
- Regulation
- 21 CFR 870.2705
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code QYU
view allMore clearances from Masimo Corporation
view allAdverse events under product code QYU
product code QYU- Death
- 3
- Total
- 3
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.