Neuronaute with IceCap 2 & IceCap 2 Small
K-Number: K223644 · 2023-01-12
ApplicantBioserenity
Decision Date2023-01-12
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Neuronaute with IceCap 2 & IceCap 2 Small is a medical device manufactured by Bioserenity. It received FDA 510(k) clearance on 2023-01-12 under approval number K223644. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Neuronaute with IceCap 2 & IceCap 2 Small?
Neuronaute with IceCap 2 & IceCap 2 Small is a medical device that received FDA 510(k) clearance on 2023-01-12. It is manufactured by Bioserenity. The 510(k) number is K223644.
When was Neuronaute with IceCap 2 & IceCap 2 Small approved by the FDA?
Neuronaute with IceCap 2 & IceCap 2 Small received FDA 510(k) clearance on 2023-01-12, under approval number K223644.
What company makes Neuronaute with IceCap 2 & IceCap 2 Small?
Neuronaute with IceCap 2 & IceCap 2 Small is manufactured by Bioserenity.
What is the FDA product code for Neuronaute with IceCap 2 & IceCap 2 Small?
The FDA product code for Neuronaute with IceCap 2 & IceCap 2 Small is GWQ.
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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.