Orchid Safety Release Valve(TM)— 510(k) K212064
Substantially EquivalentLinear Health Sciences, LLC
FDA 510(k) clearance K212064 for Orchid Safety Release Valve(TM), Substantially Equivalent on 2022-05-03. Applicant: Linear Health Sciences, LLC.
Clearance details
- Applicant
- Linear Health Sciences, LLC
- Product code
- Code QOI
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oklahoma City, OK, US
Adverse events under product code QOI
product code QOI- Other
- 1
- Total
- 1
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.