Clearance Summary
RS BIOTECH GALAXY 'R' CO2 INCUBATOR received FDA 510(k) clearance under submission number K003184, sponsored by Zander Medical Supplies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2000-11-20.
- Submission: K003184
- Applicant / Sponsor: Zander Medical Supplies, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6120
- Decision date: 2000-11-20
Classification & Regulation
This clearance is catalogued under FDA product code MQG and 21 CFR 884.6120, within the Obstetrics/Gynecology review panel as a Class II device.