510(k) K180222
K180222 is an FDA 510(k) premarket notification submitted by Medovent GmbH for the device "Reaxon Plus". The FDA issued a decision of Substantially Equivalent on April 24, 2018. The device falls under product code JXI (Cuff, Nerve), a Class II device regulated under 21 CFR 882.5275. Medovent GmbH has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 24, 2018
- Date Received
- January 25, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cuff, Nerve
- Device Class
- Class II
- Regulation Number
- 882.5275
- Review Panel
- NE
- Submission Type