Clearance Summary
4002 INFANT SCALE FOR INCUBATORS AND WARMERS received FDA 510(k) clearance under submission number K935609, 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 1994-07-01.
- Submission: K935609
- Applicant / Sponsor: Scale-Tronix, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5130
- Decision date: 1994-07-01
Classification & Regulation
This clearance is catalogued under FDA product code FMT and 21 CFR 880.5130, within the General Hospital review panel as a Class II device.