Clearance Summary
ROCHE AXISCAN 5 received FDA 510(k) clearance under submission number K771816, sponsored by Roche Medical Electronics, 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 1977-10-19.
- Submission: K771816
- Applicant / Sponsor: Roche Medical Electronics, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2225
- Decision date: 1977-10-19
Classification & Regulation
This clearance is catalogued under FDA product code HEM and 21 CFR 884.2225, within the Obstetrics/Gynecology review panel as a Class II device.