Clearance Summary
PORTABLE INTENSIVE CARE UNIT, MODEL PIC received FDA 510(k) clearance under submission number K000712, sponsored by Medical Research Laboratories, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2000-04-27.
- Submission: K000712
- Applicant / Sponsor: Medical Research Laboratories, Inc.
- Clearance pathway: Special
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1400
- Decision date: 2000-04-27
Classification & Regulation
This clearance is catalogued under FDA product code CCK and 21 CFR 868.1400, within the Anesthesiology review panel as a Class II device.