510(k) K223254
K223254 is an FDA 510(k) premarket notification submitted by Inomed Medizintechnik GmbH for the device "C2 Xplore". The FDA issued a decision of Substantially Equivalent on January 27, 2023. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820. Inomed Medizintechnik GmbH has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 27, 2023
- Date Received
- October 21, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve
- Device Class
- Class II
- Regulation Number
- 874.1820
- Review Panel
- EN
- Submission Type