Clearance Summary
ENVITEC MYSIGN O OXYGEN MEASURING DEVICE received FDA 510(k) clearance under submission number K122290, sponsored by Envitec-Wismar GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2013-01-23.
- Submission: K122290
- Applicant / Sponsor: Envitec-Wismar GmbH
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1720
- Decision date: 2013-01-23
Classification & Regulation
This clearance is catalogued under FDA product code CCL and 21 CFR 868.1720, within the Anesthesiology review panel as a Class II device.