Clearance Summary
MODEL 508 PATIENT MONITOR received FDA 510(k) clearance under submission number K921309, sponsored by Criticare Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1993-12-17.
- Submission: K921309
- Applicant / Sponsor: Criticare Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1890
- Decision date: 1993-12-17
Classification & Regulation
This clearance is catalogued under FDA product code BTY and 21 CFR 868.1890, within the Anesthesiology review panel as a Class II device.