Clearance Summary
BREATHE FIT received FDA 510(k) clearance under submission number K963326, sponsored by Cambridge Assoc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1997-02-12.
- Submission: K963326
- Applicant / Sponsor: Cambridge Assoc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3900
- Decision date: 1997-02-12
Classification & Regulation
This clearance is catalogued under FDA product code LWF and 21 CFR 874.3900, within the Ear, Nose, Throat review panel as a Class I device.