Clearance Summary
HONEYWELL HOMMED CENTRAL STATION 4.0 received FDA 510(k) clearance under submission number K072272, sponsored by Honeywell Hommed, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2007-09-07.
- Submission: K072272
- Applicant / Sponsor: Honeywell Hommed, LLC
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2007-09-07
Classification & Regulation
This clearance is catalogued under FDA product code DXN and 21 CFR 870.1130, within the Cardiovascular review panel as a Class II device.