Fundus On Phone Non Mydriatic (FOP NM-10)— 510(k) K252120
Substantially EquivalentRemidio Innovative Solutions Private Limited
FDA 510(k) clearance K252120 for Fundus On Phone Non Mydriatic (FOP NM-10), Substantially Equivalent on 2025-12-12. Applicant: Remidio Innovative Solutions Private Limited. Device class: 2.
Clearance details
- Applicant
- Remidio Innovative Solutions Private Limited
- Product code
- Code HKI
- Device class
- Class 2
- Regulation
- 21 CFR 886.1120
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bengaluru, IN
Recent devices under product code HKI
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