NFC-700 non-mydriatic auto fundus camera
K-Number: K182199 · 2019-01-02
ApplicantCrystalvue Medical Corporation
Decision Date2019-01-02
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
NFC-700 non-mydriatic auto fundus camera is a medical device manufactured by Crystalvue Medical Corporation. It received FDA 510(k) clearance on 2019-01-02 under approval number K182199. 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 NFC-700 non-mydriatic auto fundus camera?
NFC-700 non-mydriatic auto fundus camera is a medical device that received FDA 510(k) clearance on 2019-01-02. It is manufactured by Crystalvue Medical Corporation. The 510(k) number is K182199.
When was NFC-700 non-mydriatic auto fundus camera approved by the FDA?
NFC-700 non-mydriatic auto fundus camera received FDA 510(k) clearance on 2019-01-02, under approval number K182199.
What company makes NFC-700 non-mydriatic auto fundus camera?
NFC-700 non-mydriatic auto fundus camera is manufactured by Crystalvue Medical Corporation.
What is the FDA product code for NFC-700 non-mydriatic auto fundus camera?
The FDA product code for NFC-700 non-mydriatic auto fundus camera 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.