Non-Normalizing Quantitative Electroencephalograph Software
Electrode junction box standard composition
3manufacturers in China registered for this device type
28catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Nihon Kohden America, Inc., United States |
|---|---|
| FDA product code | OLT |
| Device type | Non-Normalizing Quantitative Electroencephalograph Software |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-24 |
| Record revised | 2024-04-15 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| A/DCIN1200 | In distribution | ||
| KC-001A | In distribution | ||
| DI-120A | In distribution | ||
| A/PHOTIC-3 | In distribution | ||
| JE-228AK | In distribution | ||
| JE-921A | In distribution | ||
| JE-120A-22 | In distribution | ||
| JE-212A | In distribution | ||
| QP-160AK | In distribution | ||
| BC-112B | In distribution | ||
| NK-LS-901AJ | In distribution | ||
| JE-227AK | In distribution | ||
| JE-225AK | In distribution | ||
| JE-922A | In distribution | ||
| A/POUCHTRIFOLD | In distribution | ||
| NC-143E | 4 | In distribution | |
| KE-122A | In distribution | ||
| LS-120AJ | In distribution | ||
| QD-120A | In distribution | ||
| EEG-1200A-DT | In distribution | ||
| AAA-16060 | In distribution | ||
| QI-122A | In distribution | ||
| JE-915A | In distribution | ||
| LS-703A | In distribution | ||
| JE-120A-23 | In distribution | ||
| A/NWB-HL7NIS | In distribution | ||
| QP-110AK | In distribution | ||
| EEG-1200A-RAID | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Non-Normalizing Quantitative Electroencephalograph Software | Nihon Kohden Corp. | 18 |
| Neurofax | Nihon Kohden America, Inc. | 14 |
| Stratus EEG | Kvikna Medical ehf | 4 |
| Nihon Kohden, EEG-1200A Series Neurofax | Nihon Kohden Corp. | 4 |
| Component Neuromonitoring System | Moberg Research, Inc. | 3 |
| Easy III | Cadwell Industries, Inc. | 3 |
| GCX | Nihon Kohden America, Inc. | 3 |
| Neurofax | Nihon Kohden Corp. | 2 |
| Non-Normalizing Quantitative Electroencephalograph Software | GE Healthcare Finland OY | 2 |
| E-Eegx | GE Healthcare Finland OY | 1 |
| Lifelines iEEG Portable Yoga Tablet No Video | Kvikna Medical ehf | 1 |
| Persyst Mobile App | Persyst Development LLC | 1 |
Showing 12 of 38. All products under Non-Normalizing Quantitative Electroencephalograph Software
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K080546 | 2008-08-29 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.