FDA 510(k)

SENSOSEEG Depth Electrodes

K-Number: K213170 · 2023-04-18

Decision Date2023-04-18

Product CodeGZL

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

SENSOSEEG Depth Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Sensomedical Labs, Ltd.. It received FDA 510(k) clearance on 2023-04-18 under 510(k) number K213170. 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 SENSOSEEG Depth Electrodes?

SENSOSEEG Depth Electrodes is a medical device that received FDA 510(k) clearance on 2023-04-18. The listed applicant is Sensomedical Labs, Ltd.. The 510(k) number is K213170.

When did SENSOSEEG Depth Electrodes receive FDA 510(k) clearance?

SENSOSEEG Depth Electrodes received FDA 510(k) clearance on 2023-04-18, under 510(k) number K213170.

Who is the listed applicant for SENSOSEEG Depth Electrodes?

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

What is the FDA product code for SENSOSEEG Depth Electrodes?

The FDA product code for SENSOSEEG Depth Electrodes is GZL.

Other records listing Sensomedical Labs, Ltd. 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.

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Official Source

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