Clearance Summary
BINGO PRO received FDA 510(k) clearance under submission number K111474, sponsored by Forum Engineering Technologies (96) , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2011-11-02.
- Submission: K111474
- Applicant / Sponsor: Forum Engineering Technologies (96) , Ltd.
- Clearance pathway: Traditional
- Review panel: Unknown
- Device class:
- Decision date: 2011-11-02
Classification & Regulation
This clearance is catalogued under FDA product code LQY , within the Unknown review panel as a device.