Clearance Summary
CMS 6000 received FDA 510(k) clearance under submission number K792380, sponsored by Physio-Control Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1980-01-04.
- Submission: K792380
- Applicant / Sponsor: Physio-Control Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1855
- Decision date: 1980-01-04
Classification & Regulation
This clearance is catalogued under FDA product code GYE and 21 CFR 882.1855, within the Neurology review panel as a Class II device.