Clearance Summary
DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 received FDA 510(k) clearance under submission number K040831, sponsored by Datex-Ohmeda, 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 2004-09-02.
- Submission: K040831
- Applicant / Sponsor: Datex-Ohmeda, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2710
- Decision date: 2004-09-02
Classification & Regulation
This clearance is catalogued under FDA product code DPZ and 21 CFR 870.2710, within the Cardiovascular review panel as a Class II device.