Eyer Retinal Camera NM-STD
K-Number: K221329 · 2023-02-22
ApplicantPhelcom Technologies
Decision Date2023-02-22
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
Eyer Retinal Camera NM-STD is a medical device manufactured by Phelcom Technologies. It received FDA 510(k) clearance on 2023-02-22 under approval number K221329. 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 Eyer Retinal Camera NM-STD?
Eyer Retinal Camera NM-STD is a medical device that received FDA 510(k) clearance on 2023-02-22. It is manufactured by Phelcom Technologies. The 510(k) number is K221329.
When was Eyer Retinal Camera NM-STD approved by the FDA?
Eyer Retinal Camera NM-STD received FDA 510(k) clearance on 2023-02-22, under approval number K221329.
What company makes Eyer Retinal Camera NM-STD?
Eyer Retinal Camera NM-STD is manufactured by Phelcom Technologies.
What is the FDA product code for Eyer Retinal Camera NM-STD?
The FDA product code for Eyer Retinal Camera NM-STD 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.