510(k) K213170
K213170 is an FDA 510(k) premarket notification submitted by Sensomedical Labs, Ltd. for the device "SENSOSEEG Depth Electrodes". The FDA issued a decision of Substantially Equivalent on April 18, 2023. The device falls under product code GZL (Electrode, Depth), a Class II device regulated under 21 CFR 882.1330. Sensomedical Labs, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 18, 2023
- Date Received
- September 28, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Depth
- Device Class
- Class II
- Regulation Number
- 882.1330
- Review Panel
- NE
- Submission Type