Data / Medical devices / United States / Nihon Kohden Digital Health Solutions, LLC.
Nihon Kohden Digital Health Solutions, LLC.: FDA-registered device maker in Irvine, CA, United States, 3 510(k) clearances
Nihon Kohden Digital Health Solutions, LLC. is registered with the FDA (registration 2032233) in Irvine, CA, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 5, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2032233
- FEI number
- 3003142870
- Address
- 14 Bunsen, Irvine, CA, United States, 92618
- Owner or operator
- NIHON KOHDEN CORP. (8030227)
- Roles
- Manufacturer
- First device listed
- December 19, 2011
- Registered through
- 2027
- Brand names listed
- Life Scope Central Station, NGNK-MultiSite, NK RemoteSense, NetKonnect Remote Network Extension, Next Generation NetKonnect
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Amplifier And Signal Conditioner, Transducer Signal | DRQ | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | 2 | Manufacturer | accessdata.fda.gov |
| System, Network And Communication, Physiological Monitors | MSX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 5, 2025 | K242750 | Central Station | MSX | Substantially Equivalent | Nihon Kohden Digital Health Solutions, LLC | accessdata.fda.gov |
| July 29, 2022 | K220989 | Next Generation NetKonnect | MHX | Substantially Equivalent | Nihon Kohden Digital Health Solutions, Inc. | accessdata.fda.gov |
| December 9, 2011 | K112637 | NETKONNECT REMOTE NETWORK EXTENSION | MHX | Substantially Equivalent | Nihon Kohden | accessdata.fda.gov |
Compare with other makers
- All makers of Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- All makers of Amplifier And Signal Conditioner, Transducer Signal
- All makers of System, Network And Communication, Physiological Monitors
Updated June 5, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.