Clearance Summary
SIGMA 8000 AND SIGMA 8002 received FDA 510(k) clearance under submission number K950766, sponsored by Sigma Intl. General Medical Apparatus, 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 1995-03-22.
- Submission: K950766
- Applicant / Sponsor: Sigma Intl. General Medical Apparatus, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 1995-03-22
Classification & Regulation
This clearance is catalogued under FDA product code FRN and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.