CO2mbiLED
K-Number: K201096 · 2020-06-23
ApplicantKarl Storz Endoscopy America, Inc.
Decision Date2020-06-23
Product CodeFCX
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
CO2mbiLED is a medical device manufactured by Karl Storz Endoscopy America, Inc.. It received FDA 510(k) clearance on 2020-06-23 under approval number K201096. The device is classified under product code FCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CO2mbiLED?
CO2mbiLED is a medical device that received FDA 510(k) clearance on 2020-06-23. It is manufactured by Karl Storz Endoscopy America, Inc.. The 510(k) number is K201096.
When was CO2mbiLED approved by the FDA?
CO2mbiLED received FDA 510(k) clearance on 2020-06-23, under approval number K201096.
What company makes CO2mbiLED?
CO2mbiLED is manufactured by Karl Storz Endoscopy America, Inc..
What is the FDA product code for CO2mbiLED?
The FDA product code for CO2mbiLED is FCX.
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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.