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FDA 510(k)

NUNA LUX (NUNL528)

K-Number: K233862 · 2024-03-01

ApplicantPremier North America, Inc.
Decision Date2024-03-01
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NUNA LUX (NUNL528) is the device name listed in this FDA 510(k) record. The listed applicant is Premier North America, Inc.. It received FDA 510(k) clearance on 2024-03-01 under 510(k) number K233862. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NUNA LUX (NUNL528)?

NUNA LUX (NUNL528) is a medical device that received FDA 510(k) clearance on 2024-03-01. The listed applicant is Premier North America, Inc.. The 510(k) number is K233862.

When did NUNA LUX (NUNL528) receive FDA 510(k) clearance?

NUNA LUX (NUNL528) received FDA 510(k) clearance on 2024-03-01, under 510(k) number K233862.

Who is the listed applicant for NUNA LUX (NUNL528)?

The FDA 510(k) record lists Premier North America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NUNA LUX (NUNL528)?

The FDA product code for NUNA LUX (NUNL528) is OHS.

Other records listing Premier North America, Inc. 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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