Clearance Summary
SANITAS PATIENT SCALE received FDA 510(k) clearance under submission number K930626, sponsored by Dutton-Lainson 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 1993-08-06.
- Submission: K930626
- Applicant / Sponsor: Dutton-Lainson Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.2720
- Decision date: 1993-08-06
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.