Clearance Summary
LOSS OF RESISTANCE SYRINGE received FDA 510(k) clearance under submission number K061737, sponsored by Robert Busse & Co., 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 2006-12-18.
- Submission: K061737
- Applicant / Sponsor: Robert Busse & Co., Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5140
- Decision date: 2006-12-18
Classification & Regulation
This clearance is catalogued under FDA product code CAZ and 21 CFR 868.5140, within the Anesthesiology review panel as a Class II device.