Clearance Summary
Model 9100 PFT/DICO received FDA 510(k) clearance under submission number K221030, sponsored by Vitalograph Ireland, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2022-07-15.
- Submission: K221030
- Applicant / Sponsor: Vitalograph Ireland, Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1890
- Decision date: 2022-07-15
Classification & Regulation
This clearance is catalogued under FDA product code BTY and 21 CFR 868.1890, within the Anesthesiology review panel as a Class II device.