STIMULATOR MODEL 8021— 510(k) K780539
Substantially EquivalentLife-Tech Instruments, Inc.
FDA 510(k) clearance K780539 for STIMULATOR MODEL 8021, Substantially Equivalent on 1978-06-22. Applicant: Life-Tech Instruments, Inc..
Clearance details
- Applicant
- Life-Tech Instruments, Inc.
- Product code
- Code GWF
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code GWF
product code GWF- Malfunction
- 2,364
- Other
- 4
- Total
- 2,368
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.