510(k) K913301— MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM
Substantially EquivalentComet North America, Inc.
Clearance details
- Applicant
- Comet North America, Inc.
- Product code
- Code ITY
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Norwalk, CT, US
Adverse events under product code ITY
product code ITY- 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.