Clearance Summary
PATIENT TURNING AND REPOSITIONING G DEV. received FDA 510(k) clearance under submission number K770499, sponsored by Patient Healthguards Corp.. 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 1977-04-29.
- Submission: K770499
- Applicant / Sponsor: Patient Healthguards Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6785
- Decision date: 1977-04-29
Classification & Regulation
This clearance is catalogued under FDA product code FMR and 21 CFR 880.6785, within the General Hospital review panel as a Class I device.