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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Bioserenity. It received FDA 510(k) clearance on 2023-01-12 under 510(k) 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. The listed applicant is Bioserenity. The 510(k) number is K223644.

When did Neuronaute with IceCap 2 & IceCap 2 Small receive FDA 510(k) clearance?

Neuronaute with IceCap 2 & IceCap 2 Small received FDA 510(k) clearance on 2023-01-12, under 510(k) number K223644.

Who is the listed applicant for Neuronaute with IceCap 2 & IceCap 2 Small?

The FDA 510(k) record lists Bioserenity as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Bioserenity as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K170138NEURONAUTE

Related Devices (Code: GWQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.K260455New Wave SystemZeto, Inc.K233403Flexset SystemZeto, Inc.K231366Neuronaute PlusBioserenity SasK221959Q21Neurofield, Inc.K231457SPARK ScanSpark Neuro, Inc.

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.

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