Clearance Summary
CYBERRX MODEL 7200 received FDA 510(k) clearance under submission number K934434, sponsored by Cybermed Control Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1995-01-24.
- Submission: K934434
- Applicant / Sponsor: Cybermed Control Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.1400
- Decision date: 1995-01-24
Classification & Regulation
This clearance is catalogued under FDA product code FFT and 21 CFR 876.1400, within the Gastroenterology, Urology review panel as a Class I device.