Fundus On Phone Non Mydriatic (FOP NM-10)
K-Number: K252120 · 2025-12-12
Decision Date2025-12-12
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
Fundus On Phone Non Mydriatic (FOP NM-10) is a medical device manufactured by Remidio Innovative Solutions Private Limited. It received FDA 510(k) clearance on 2025-12-12 under approval number K252120. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Fundus On Phone Non Mydriatic (FOP NM-10)?
Fundus On Phone Non Mydriatic (FOP NM-10) is a medical device that received FDA 510(k) clearance on 2025-12-12. It is manufactured by Remidio Innovative Solutions Private Limited. The 510(k) number is K252120.
When was Fundus On Phone Non Mydriatic (FOP NM-10) approved by the FDA?
Fundus On Phone Non Mydriatic (FOP NM-10) received FDA 510(k) clearance on 2025-12-12, under approval number K252120.
What company makes Fundus On Phone Non Mydriatic (FOP NM-10)?
Fundus On Phone Non Mydriatic (FOP NM-10) is manufactured by Remidio Innovative Solutions Private Limited.
What is the FDA product code for Fundus On Phone Non Mydriatic (FOP NM-10)?
The FDA product code for Fundus On Phone Non Mydriatic (FOP NM-10) is HKI.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.