Clearance Summary
BREATHE EASY, MODELS AD AND CD received FDA 510(k) clearance under submission number K981841, sponsored by Respiraid , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1998-10-13.
- Submission: K981841
- Applicant / Sponsor: Respiraid , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5045
- Decision date: 1998-10-13
Classification & Regulation
This clearance is catalogued under FDA product code FRF and 21 CFR 880.5045, within the General Hospital review panel as a Class II device.