Chromophare
Berchtold Surgical Light System ? Wall Mounted
5manufacturers in China registered for this device type
1catalogue number
11510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (2), Shandong (1), Jiangxi (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Kaiyan Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Beijing Aeonmed Co., Ltd. | Sanhe | Hebei | Contract manufacturer | 7 |
| Guangdong Kareway Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 16 |
| Shandong Deman Medical Equipment Group Co., Ltd. | Jining | Shandong | Manufacturer | 11 |
| Nanchang Micare Medical Equipment Co., Ltd. | Nanchang | Jiangxi | Manufacturer | 8 |
Record
| Listed by | Berchtold Gmbh & Co. KG, Germany |
|---|---|
| FDA product code | FSY |
| Device type | Light, Surgical, Ceiling Mounted |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4580 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-23 |
| Record revised | 2024-02-22 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Storage environment temperature -20 to 70 °C; Handling environment temperature -20 to 70 °C; Handling environment humidity 0 to 90 % RH; Storage environment humidity 0 to 90 % RH; Handling environment atmospheric pressure 50 to 106 KiloPascal; Storage environment atmospheric pressure 50 to 106 KiloPascal |
| Distribution end date | 2024-02-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CW00000001 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HarmonyAIR | Steris Corporation | 1,344 |
| Volista | Maquet Gmbh | 677 |
| iCE Surgical Light | Amico Clinical Solutions | 599 |
| Powerled TM | Maquet Gmbh | 287 |
| Devon | Cardinal Health | 70 |
| Light, Surgical, Ceiling Mounted | Maquet Gmbh | 68 |
| Alyon | Steris Corporation | 64 |
| Medical Boom | Amico Clinical Solutions | 56 |
| Standop Volista® | Maquet Gmbh | 50 |
| Amtai | Amtai Medical Equipment, Inc. | 45 |
| Mira Minor Surgery Light | Amico Lights Corporation | 24 |
| MI Product Line | Medical Illumination International, Inc | 20 |
Showing 12 of 191. All products under Light, Surgical, Ceiling Mounted
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K120392 | 2012-02-16 |
| K090378 | 2009-02-23 |
| K083066 | 2008-10-30 |
| K080857 | 2008-04-10 |
| K024132 | 2003-03-21 |
| K990656 | 1999-07-20 |
| K991527 | 1999-05-27 |
| K974433 | 1998-02-20 |
| K965130 | 1997-07-14 |
| K944855 | 1994-10-19 |
| K922836 | 1992-10-09 |
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.