Monaghan medical filtered mouthpiece kit— 510(k) K220145
Substantially EquivalentMonaghan Medical Corporation
FDA 510(k) clearance K220145 for Monaghan medical filtered mouthpiece kit, Substantially Equivalent on 2023-08-24. Applicant: Monaghan Medical Corporation. Device class: 2.
Clearance details
- Applicant
- Monaghan Medical Corporation
- Product code
- Code CAF
- Device class
- Class 2
- Regulation
- 21 CFR 868.5630
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plattsburgh, NY, US
Recent devices under product code CAF
view allMore clearances from Monaghan Medical Corporation
view allAdverse events under product code CAF
product code CAF- Death
- 22
- Injury
- 125
- Malfunction
- 613
- Other
- 11
- Total
- 771
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.