Clearance Summary
PREMIER 11 HOLTER received FDA 510(k) clearance under submission number K062088, sponsored by Diagnostic Monitoring Software. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2006-08-25.
- Submission: K062088
- Applicant / Sponsor: Diagnostic Monitoring Software
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 2006-08-25
Classification & Regulation
This clearance is catalogued under FDA product code MLO and 21 CFR 870.2800, within the Cardiovascular review panel as a Class II device.