Clearance Summary
DIFFUSION SYSTEM, SINGLE-BREATH (47404A) received FDA 510(k) clearance under submission number K760169, sponsored by Hewlett-Packard Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1976-07-20.
- Submission: K760169
- Applicant / Sponsor: Hewlett-Packard Co.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1430
- Decision date: 1976-07-20
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.