FDA 510(k)

iCE-SG2 Subcutaneous Electrode Kit

K-Number: K222706 · 2022-12-06

Decision Date2022-12-06

Product CodeGZL

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

iCE-SG2 Subcutaneous Electrode Kit is a medical device manufactured by Ice Neurosystems, Inc.. It received FDA 510(k) clearance on 2022-12-06 under approval number K222706. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iCE-SG2 Subcutaneous Electrode Kit?

iCE-SG2 Subcutaneous Electrode Kit is a medical device that received FDA 510(k) clearance on 2022-12-06. It is manufactured by Ice Neurosystems, Inc.. The 510(k) number is K222706.

When was iCE-SG2 Subcutaneous Electrode Kit approved by the FDA?

iCE-SG2 Subcutaneous Electrode Kit received FDA 510(k) clearance on 2022-12-06, under approval number K222706.

What company makes iCE-SG2 Subcutaneous Electrode Kit?

iCE-SG2 Subcutaneous Electrode Kit is manufactured by Ice Neurosystems, Inc..

What is the FDA product code for iCE-SG2 Subcutaneous Electrode Kit?

The FDA product code for iCE-SG2 Subcutaneous Electrode Kit is GZL.

Other Devices by Ice Neurosystems, Inc.

K191868iCEWav Neuromonitoring Platform K201678iCE-SG Subcutaneous Electrode Arrays

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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.