510(k) K152571
K152571 is an FDA 510(k) premarket notification submitted by Biegler GmbH for the device "Stivax". The FDA issued a decision of Substantially Equivalent on May 26, 2016. The device falls under product code BWK (Stimulator, Electro-Acupuncture), a Class U device. Biegler GmbH has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 26, 2016
- Date Received
- September 9, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Electro-Acupuncture
- Device Class
- Class U
- Regulation Number
- Review Panel
- NE
- Submission Type