Clearance Summary
ivWatch Model 400 received FDA 510(k) clearance under submission number K153605, sponsored by Ivwatch, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2016-02-11.
- Submission: K153605
- Applicant / Sponsor: Ivwatch, LLC
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2016-02-11
Classification & Regulation
This clearance is catalogued under FDA product code PMS and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.