SENSOSEEG Depth Electrodes
K-Number: K213170 · 2023-04-18
ApplicantSensomedical Labs, Ltd.
Decision Date2023-04-18
Product CodeGZL
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
SENSOSEEG Depth Electrodes is a medical device manufactured by Sensomedical Labs, Ltd.. It received FDA 510(k) clearance on 2023-04-18 under approval 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. It is manufactured by Sensomedical Labs, Ltd.. The 510(k) number is K213170.
When was SENSOSEEG Depth Electrodes approved by the FDA?
SENSOSEEG Depth Electrodes received FDA 510(k) clearance on 2023-04-18, under approval number K213170.
What company makes SENSOSEEG Depth Electrodes?
SENSOSEEG Depth Electrodes is manufactured by Sensomedical Labs, Ltd..
What is the FDA product code for SENSOSEEG Depth Electrodes?
The FDA product code for SENSOSEEG Depth Electrodes is GZL.
Related Clinical Trials
Other Devices by Sensomedical Labs, Ltd.
Related Devices (Code: GZL)
K151790PMT Platinum Depthalon Depth ElectrodePmt Corporation
K152547DNAP ElectrodeAd-Tech Medical Instrument Corporation
K171581Neuro Omega SystemAlpha Omega Engineering , Ltd.
K170959DIXI Medical Microdeep Depth ElectrodeDixi Medical
K162459AccuPoint ElectrodeMicroprobes For Life Science, Inc. Dba Neuron
K163355Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth ElectrodesAd-Tech Medical Instrument Corporation
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.