Clearance Summary
MULTIPLE NAME MODEL MULTIPLE received FDA 510(k) clearance under submission number K093759, sponsored by Gx Corporation Sdn Bhd (Plant 1). The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2010-02-19.
- Submission: K093759
- Applicant / Sponsor: Gx Corporation Sdn Bhd (Plant 1)
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2010-02-19
Classification & Regulation
This clearance is catalogued under FDA product code LZA and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.