EASYSCAN MODEL 1.2— 510(k) K111988
Substantially EquivalentI-Optics BV
FDA 510(k) clearance K111988 for EASYSCAN MODEL 1.2, Substantially Equivalent on 2011-10-28. Applicant: I-Optics BV. Device class: 2.
Clearance details
- Applicant
- I-Optics BV
- Product code
- Code MYC
- Device class
- Class 2
- Regulation
- 21 CFR 886.1570
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Claremont, NH, US
Recent devices under product code MYC
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