Clearance Summary
Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6102C Series: 6102CA, 6102CP, 6102CI, 6102CN), Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor, Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Senso received FDA 510(k) clearance under submission number K160865, sponsored by Nonin Medical, 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 2016-08-05.
- Submission: K160865
- Applicant / Sponsor: Nonin Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 2016-08-05
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.