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FDA 510(k)

ClarifEye R1.0, ClarifEye Needle

K-Number: K201743 · 2021-02-23

ApplicantPhilips Medical Systems Nederlands B.V.
Decision Date2021-02-23
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ClarifEye R1.0, ClarifEye Needle is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederlands B.V.. It received FDA 510(k) clearance on 2021-02-23 under 510(k) 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. The listed applicant is Philips Medical Systems Nederlands B.V.. The 510(k) number is K201743.

When did ClarifEye R1.0, ClarifEye Needle receive FDA 510(k) clearance?

ClarifEye R1.0, ClarifEye Needle received FDA 510(k) clearance on 2021-02-23, under 510(k) number K201743.

Who is the listed applicant for ClarifEye R1.0, ClarifEye Needle?

The FDA 510(k) record lists Philips Medical Systems Nederlands B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ClarifEye R1.0, ClarifEye Needle?

The FDA product code for ClarifEye R1.0, ClarifEye Needle is OWB.

Other records listing Philips Medical Systems Nederlands B.V. as applicant

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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.

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