Clearance Summary
VITALOGRAPH-BREATHCO MONITOR received FDA 510(k) clearance under submission number K892524, sponsored by Vitalograph , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1989-05-05.
- Submission: K892524
- Applicant / Sponsor: Vitalograph , Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1430
- Decision date: 1989-05-05
Classification & Regulation
This clearance is catalogued under FDA product code CCJ and 21 CFR 868.1430, within the Anesthesiology review panel as a Class II device.