FDA device listing
A/POUCH-JE922,A/POUCHTRIFOLD,BC-112B,EEG-9100A,EEG-9200A,JE-207A,JE-208A,JE-209A,JE-212A,JE-215AK,JE-216AK,JE-217AK,JE-4…
FDA device listing 2027286187 · NIHON KOHDEN CORP.
Key facts
| Proprietary names | A/POUCH-JE922,A/POUCHTRIFOLD,BC-112B,EEG-9100A,EEG-9200A,JE-207A,JE-208A,JE-209A,JE-212A,JE-215AK,JE-216AK,JE-217AK,JE-425A,JE-912AK,JE-921A,JE-922A,JL-550T1,KC-001A,KE-910A,LS-703A,LS-703AA,LS-901AJ,NC-143E,NE-134A,NE-311A,NEUROFAX, MODELS EEG-1100A with EEG-9100A AND JUNCTION BOX FUNCTIONS,QI-120A,QP-110AK,QP-150AK,TG-921T3,TL-052S,TL-062S,TL-201T,TL-220T,TL-271T,TL-273T,TL-274T,YZ-0226 |
|---|---|
| Owner/operator | NIHON KOHDEN CORP. |
| Owner/operator number | 8030227 |
| Premarket submissions | K011204 |
| Product codes | GWQ, OLV |
| Device names | GWQ - Full-Montage Standard Electroencephalograph, OLV - Standard Polysomnograph With Electroencephalograph |
| Device class | Class II |
| Classification regulations (21 CFR) | 882.1400 |
| Review panels | Neurology |
| Registered establishments | NIHON KOHDEN AMERICA, INC., NIHON KOHDEN CORP., Nihon Kohden Corporation - Eastern Japan Logistics Center, Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center, Nihon Kohden Tomioka Corporation, NIHON KOHDEN TOMIOKA PRODUCTION CENTER |
| Establishment registrations | 2080783, 8030229, 9611252, 3007962724, 3013501110, 3016852448 |
| FEI numbers | 2080783, 3002807720, 3002807739, 3007962724, 3013501110, 3016852448 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer, Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database