Clearance Summary
BES - BREATH EXPOSURE SYNCHRONIZER received FDA 510(k) clearance under submission number K942581, sponsored by The Henry G. Dietz Co., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1994-12-12.
- Submission: K942581
- Applicant / Sponsor: The Henry G. Dietz Co., Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 1994-12-12
Classification & Regulation
This clearance is catalogued under FDA product code KPR and 21 CFR 892.1680, within the Radiology review panel as a Class II device.