Clearance Summary
ENVITEC REUSABLE SOFTIP Y SPO2 SENSORS received FDA 510(k) clearance under submission number K060675, sponsored by Envitec-Wismar GmbH. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2006-07-17.
- Submission: K060675
- Applicant / Sponsor: Envitec-Wismar GmbH
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 2006-07-17
Classification & Regulation
This clearance is catalogued under FDA product code DQA and 21 CFR 870.2700, within the Cardiovascular review panel as a Class II device.