ClarifEye R1.0, ClarifEye Needle
K-Number: K201743 · 2021-02-23
Decision Date2021-02-23
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
ClarifEye R1.0, ClarifEye Needle is a medical device manufactured by Philips Medical Systems Nederlands B.V.. It received FDA 510(k) clearance on 2021-02-23 under approval number K201743. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ClarifEye R1.0, ClarifEye Needle?
ClarifEye R1.0, ClarifEye Needle is a medical device that received FDA 510(k) clearance on 2021-02-23. It is manufactured by Philips Medical Systems Nederlands B.V.. The 510(k) number is K201743.
When was ClarifEye R1.0, ClarifEye Needle approved by the FDA?
ClarifEye R1.0, ClarifEye Needle received FDA 510(k) clearance on 2021-02-23, under approval number K201743.
What company makes ClarifEye R1.0, ClarifEye Needle?
ClarifEye R1.0, ClarifEye Needle is manufactured by Philips Medical Systems Nederlands B.V..
What is the FDA product code for ClarifEye R1.0, ClarifEye Needle?
The FDA product code for ClarifEye R1.0, ClarifEye Needle is OWB.
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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.