Decision Date2021-11-17
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Qora Stool Management Kit is a medical device manufactured by Cm Technologies, Inc.. It received FDA 510(k) clearance on 2021-11-17 under approval number K212444. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Qora Stool Management Kit?
Qora Stool Management Kit is a medical device that received FDA 510(k) clearance on 2021-11-17. It is manufactured by Cm Technologies, Inc.. The 510(k) number is K212444.
When was Qora Stool Management Kit approved by the FDA?
Qora Stool Management Kit received FDA 510(k) clearance on 2021-11-17, under approval number K212444.
What company makes Qora Stool Management Kit?
Qora Stool Management Kit is manufactured by Cm Technologies, Inc..
What is the FDA product code for Qora Stool Management Kit?
The FDA product code for Qora Stool Management Kit is KNT.
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Official Source
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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.