Clearance Summary
NEONATAL ENVIRONMENTAL MONITOR, MODEL 275 received FDA 510(k) clearance under submission number K891674, sponsored by Preemicare Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1989-08-31.
- Submission: K891674
- Applicant / Sponsor: Preemicare Corp.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1720
- Decision date: 1989-08-31
Classification & Regulation
This clearance is catalogued under FDA product code CCL and 21 CFR 868.1720, within the Anesthesiology review panel as a Class II device.