Lux 35 Detector
K-Number: K203159 · 2020-12-02
ApplicantCarestream Health
Decision Date2020-12-02
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Lux 35 Detector is a medical device manufactured by Carestream Health. It received FDA 510(k) clearance on 2020-12-02 under approval number K203159. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Lux 35 Detector?
Lux 35 Detector is a medical device that received FDA 510(k) clearance on 2020-12-02. It is manufactured by Carestream Health. The 510(k) number is K203159.
When was Lux 35 Detector approved by the FDA?
Lux 35 Detector received FDA 510(k) clearance on 2020-12-02, under approval number K203159.
What company makes Lux 35 Detector?
Lux 35 Detector is manufactured by Carestream Health.
What is the FDA product code for Lux 35 Detector?
The FDA product code for Lux 35 Detector is MQB.
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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.