Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ) +1 more— 510(k) K230569
Substantially EquivalentCardinalhealth
FDA 510(k) clearance K230569 for Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ) +1 more, Substantially Equivalent on 2023-07-03. Applicant: Cardinalhealth. Device class: 2.
Clearance details
- Device name as filed
- Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 )
- Applicant
- Cardinalhealth
- Product code
- Code FXX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Waukegan, IL, US
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Adverse events under product code FXX
product code FXX- Injury
- 137
- Total
- 137
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.