Clearance Summary
Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) received FDA 510(k) clearance under submission number K233963, sponsored by Taiwan Aulisa Medical Devices Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2025-02-25.
- Submission: K233963
- Applicant / Sponsor: Taiwan Aulisa Medical Devices Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 2025-02-25
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.