Disposable Goggle Foam
Disposable Goggle Foam; 10pk
3manufacturers in China registered for this device type
1catalogue number
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 | Cadwell Industries, Inc., United States |
|---|---|
| FDA product code | OLT |
| Device type | Non-Normalizing Quantitative Electroencephalograph Software |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K162199 |
| Record published | 2017-07-11 |
| Record revised | 2024-12-23 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 2.5 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 197278-000 | Length 2.5 in | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Non-Normalizing Quantitative Electroencephalograph Software | Nihon Kohden America, Inc. | 28 |
| 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 |
Showing 12 of 38. All products under Non-Normalizing Quantitative Electroencephalograph Software
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190760 | 2019-11-23 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Cadwell Industries, Inc. | 510(k) number | 2024-05-17 | Class II | Process design | Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical stimulation. | 26 units |
| Cadwell Industries, Inc. | 510(k) number | 2024-04-23 | Class II | Process design | There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient connections resulting in potential unintended shock to the patient. | 54 units |
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.