ALLERGAN I.S.P. MODEL 3000 OPHTHALMIC SURGICAL-SYS— 510(k) K854225
Substantially EquivalentAdvanced Medical Technology, Inc.
FDA 510(k) clearance K854225 for ALLERGAN I.S.P. MODEL 3000 OPHTHALMIC SURGICAL-SYS, Substantially Equivalent on 1985-12-27. Applicant: Advanced Medical Technology, Inc..
Clearance details
- Applicant
- Advanced Medical Technology, Inc.
- Product code
- Code HQC
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westminister, CA, US
Adverse events under product code HQC
product code HQC- Injury
- 2,378
- Malfunction
- 8,768
- Total
- 11,146
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.