Clearance Summary
CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT received FDA 510(k) clearance under submission number K861555, sponsored by Respiratory Care, 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 1986-06-05.
- Submission: K861555
- Applicant / Sponsor: Respiratory Care, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5905
- Decision date: 1986-06-05
Classification & Regulation
This clearance is catalogued under FDA product code BZD and 21 CFR 868.5905, within the Anesthesiology review panel as a Class II device.