510(k) K173684
K173684 is an FDA 510(k) premarket notification submitted by G.Tec Medical Engineering GmbH for the device "g.Estim PRO". The FDA issued a decision of Substantially Equivalent on May 4, 2018. The device falls under product code GYC (Electrode, Cortical), a Class II device regulated under 21 CFR 882.1310. G.Tec Medical Engineering GmbH has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 4, 2018
- Date Received
- December 1, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Electrode, Cortical
- Device Class
- Class II
- Regulation Number
- 882.1310
- Review Panel
- NE
- Submission Type