K896368
Substantially EquivalentMODIFIED AXOSTIM
- Applicant
- Singer Medical Products, Inc.
- Product code
- BXN
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bensenville, IL, US
Adverse events under product code BXN
product code BXN- 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.