Clearance Summary
INSU COOL received FDA 510(k) clearance under submission number K885055, sponsored by Dynex Trading Co.. 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 1989-04-26.
- Submission: K885055
- Applicant / Sponsor: Dynex Trading Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class:
- Decision date: 1989-04-26
Classification & Regulation
This clearance is catalogued under FDA product code LDQ , within the General Hospital review panel as a device.