AUTO-SAFETY INJECTOR-2 (ASI-2)— 510(k) K082587
Substantially EquivalentMedical House Products Limited
FDA 510(k) clearance K082587 for AUTO-SAFETY INJECTOR-2 (ASI-2), Substantially Equivalent on 2008-10-02. Applicant: Medical House Products Limited.
Clearance details
- Applicant
- Medical House Products Limited
- Product code
- Code KZH
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sheffield, GB
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.