510(k) K200886
K200886 is an FDA 510(k) premarket notification submitted by Allotrope Medical, Inc. for the device "StimSite". The FDA issued a decision of Substantially Equivalent on November 10, 2020. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 10, 2020
- Date Received
- April 2, 2020
- 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