Clearance Summary
TONOPORT VI received FDA 510(k) clearance under submission number K170966, sponsored by Par Medizintechnik GmbH & Co. KG. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2017-06-14.
- Submission: K170966
- Applicant / Sponsor: Par Medizintechnik GmbH & Co. KG
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2017-06-14
Classification & Regulation
This clearance is catalogued under FDA product code DXN and 21 CFR 870.1130, within the Cardiovascular review panel as a Class II device.