Clearance Summary
VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX received FDA 510(k) clearance under submission number K103524, sponsored by International Biomedical, Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2011-04-15.
- Submission: K103524
- Applicant / Sponsor: International Biomedical, Ltd.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5410
- Decision date: 2011-04-15
Classification & Regulation
This clearance is catalogued under FDA product code FPL and 21 CFR 880.5410, within the General Hospital review panel as a Class II device.