Clearance Summary
AMBU TUBECHECK received FDA 510(k) clearance under submission number K981891, sponsored by Ambu, 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 1998-07-17.
- Submission: K981891
- Applicant / Sponsor: Ambu, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5730
- Decision date: 1998-07-17
Classification & Regulation
This clearance is catalogued under FDA product code BTR and 21 CFR 868.5730, within the Anesthesiology review panel as a Class II device.