K930197
Substantially EquivalentKWIK BOARD
- Applicant
- Astral, Ltd.
- Product code
- KMK
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Rafael, CA, US
Adverse events under product code KMK
product code KMK- Malfunction
- 461
- Other
- 1
- Total
- 462
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.