Clearance Summary
VR LUNG ELECTROSONOGRAPH received FDA 510(k) clearance under submission number K061495, sponsored by Deep Breeze , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2007-07-18.
- Submission: K061495
- Applicant / Sponsor: Deep Breeze , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1875
- Decision date: 2007-07-18
Classification & Regulation
This clearance is catalogued under FDA product code OCR and 21 CFR 870.1875, within the Cardiovascular review panel as a Class II device.