Clearance Summary
TOF-GUARD TRANSMISSION MONITOR received FDA 510(k) clearance under submission number K925159, sponsored by Biometer Intl. A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1993-09-01.
- Submission: K925159
- Applicant / Sponsor: Biometer Intl. A/S
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.2775
- Decision date: 1993-09-01
Classification & Regulation
This clearance is catalogued under FDA product code KOI and 21 CFR 868.2775, within the Anesthesiology review panel as a Class II device.