Clearance Summary
KAWASUMI LABORATORIES K-CUFF received FDA 510(k) clearance under submission number K930012, sponsored by Kawasumi Laboratories Co., Ltd.. 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 1993-12-14.
- Submission: K930012
- Applicant / Sponsor: Kawasumi Laboratories Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5420
- Decision date: 1993-12-14
Classification & Regulation
This clearance is catalogued under FDA product code KZD and 21 CFR 880.5420, within the General Hospital review panel as a Class I device.