Clearance Summary
Next Generation NetKonnect received FDA 510(k) clearance under submission number K220989, sponsored by Nihon Kohden Digital Health Solutions, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2022-07-29.
- Submission: K220989
- Applicant / Sponsor: Nihon Kohden Digital Health Solutions, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2022-07-29
Classification & Regulation
This clearance is catalogued under FDA product code MHX and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.