Additive Cap— 510(k) K190305
Substantially EquivalentInternational Medical Industries, Inc.
FDA 510(k) clearance K190305 for Additive Cap, Substantially Equivalent on 2019-04-30. Applicant: International Medical Industries, Inc..
Clearance details
- Applicant
- International Medical Industries, Inc.
- Product code
- Code KPE
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pompano Beach, FL, US
Adverse events under product code KPE
product code KPE- Malfunction
- 1,000
- Other
- 1
- Total
- 1,001
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.