Clearance Summary
MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS received FDA 510(k) clearance under submission number K013905, sponsored by Pro-Tech Services, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2002-04-22.
- Submission: K013905
- Applicant / Sponsor: Pro-Tech Services, Inc.
- Clearance pathway: Special
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.2375
- Decision date: 2002-04-22
Classification & Regulation
This clearance is catalogued under FDA product code MNR and 21 CFR 868.2375, within the Anesthesiology review panel as a Class II device.