Variable Polarizing Hood
An instrument that eliminates unwanted glare from surfaces that are being examined.
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shandong (1), Jiangxi (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Deman Medical Equipment Group Co., Ltd. | Jining | Shandong | Manufacturer | 11 |
| Nanchang Micare Medical Equipment Co., Ltd. | Nanchang | Jiangxi | Manufacturer | 8 |
Record
| Listed by | GlobalMed Holdings, LLC, United States |
|---|---|
| FDA product code | PEQ |
| Device type | Accessories To Examination Light |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6320 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K131338 |
| Record published | 2023-12-08 |
| Record revised | 2024-12-24 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GMD55100010 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Graft Board Round LED Backlight | Cole Instruments | 1 |
| Valo | Ultradent Products Inc. | 1 |
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.