LOBSTER AUTO-INJECTOR— 510(k) K124026
Substantially EquivalentScandinavian Health Limited
FDA 510(k) clearance K124026 for LOBSTER AUTO-INJECTOR, Substantially Equivalent on 2013-09-13. Applicant: Scandinavian Health Limited.
Clearance details
- Applicant
- Scandinavian Health Limited
- Product code
- Code KZH
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Deerfield Beach, FL, US
Adverse events under product code KZH
product code KZH- 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.