Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow— 510(k) K142398
Substantially EquivalentEllex Medical Pty, Ltd.
FDA 510(k) clearance K142398 for Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow, Substantially Equivalent on 2015-07-14. Applicant: Ellex Medical Pty, Ltd..
Clearance details
- Applicant
- Ellex Medical Pty, Ltd.
- Product code
- Code HQF
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Adelaide, AU
Adverse events under product code HQF
product code HQF- Injury
- 166
- Other
- 1
- Total
- 167
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.