Clearance Summary
MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120 received FDA 510(k) clearance under submission number K002787, sponsored by Palco Labs, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2000-11-29.
- Submission: K002787
- Applicant / Sponsor: Palco Labs, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 2000-11-29
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.