510(k) K220989
K220989 is an FDA 510(k) premarket notification submitted by Nihon Kohden Digital Health Solutions, Inc. for the device "Next Generation NetKonnect". The FDA issued a decision of Substantially Equivalent on July 29, 2022. The device falls under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.1025. Nihon Kohden Digital Health Solutions, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 29, 2022
- Date Received
- April 4, 2022
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Device Class
- Class II
- Regulation Number
- 870.1025
- Review Panel
- CV
- Submission Type