The following data is part of a premarket notification filed by Nihon Kohden Digital Health Solutions, Inc. with the FDA for Next Generation Netkonnect.
| Device ID | K220989 |
| 510k Number | K220989 |
| Device Name: | Next Generation NetKonnect |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | Nihon Kohden Digital Health Solutions, Inc. 14 Bunsen Irvine, CA 92618 |
| Contact | Maria Pronina |
| Correspondent | Maria Pronina Nihon Kohden Digital Health Solutions, Inc. 14 Bunsen Irvine, CA 92618 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-04 |
| Decision Date | 2022-07-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851725007344 | K220989 | 000 |
| 00851725007337 | K220989 | 000 |
| 00851725007313 | K220989 | 000 |
| 00851725007306 | K220989 | 000 |
| 00851725007115 | K220989 | 000 |
| 00851725007351 | K220989 | 000 |