Clearance Summary
BCI WW1020 PULSE OXIMETER, MODEL WW1020 received FDA 510(k) clearance under submission number K083705, sponsored by Smiths Medical Pm, 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 2009-04-09.
- Submission: K083705
- Applicant / Sponsor: Smiths Medical Pm, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 2009-04-09
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.