INTEGRE PRO, MODEL L2RY— 510(k) K081565
Substantially EquivalentEllex Medical Pty, Ltd.
FDA 510(k) clearance K081565 for INTEGRE PRO, MODEL L2RY, Substantially Equivalent on 2008-07-02. Applicant: Ellex Medical Pty, Ltd.. Device class: 2.
Clearance details
- Applicant
- Ellex Medical Pty, Ltd.
- Product code
- Code HQF
- Device class
- Class 2
- Regulation
- 21 CFR 886.4390
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Adelaide, South Australia, AU
Recent devices under product code HQF
view allMore clearances from Ellex Medical Pty, Ltd.
view allAdverse 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 →
Recalls naming K081565
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081565.
Data sourced from openFDA. This site is unofficial and independent of the FDA.