Clearance Summary
SCALE-TRONIX PLATFORM SCALE received FDA 510(k) clearance under submission number K912662, sponsored by Scale-Tronix, Inc.. 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 1992-03-27.
- Submission: K912662
- Applicant / Sponsor: Scale-Tronix, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.2720
- Decision date: 1992-03-27
Classification & Regulation
This clearance is catalogued under FDA product code FRW and 21 CFR 880.2720, within the General Hospital review panel as a Class I device.