Clearance Summary
ResQ Administration Set received FDA 510(k) clearance under submission number K231707, sponsored by Q For Plastic Industries. 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 2024-01-03.
- Submission: K231707
- Applicant / Sponsor: Q For Plastic Industries
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2024-01-03
Classification & Regulation
This clearance is catalogued under FDA product code FPA and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.