The following data is part of a premarket notification filed by Shenzhen Goldcare Meditech Co., Ltd. with the FDA for Gc-3000e Digital Colposcope.
| Device ID | K122311 |
| 510k Number | K122311 |
| Device Name: | GC-3000E DIGITAL COLPOSCOPE |
| Classification | Colposcope (and Colpomicroscope) |
| Applicant | SHENZHEN GOLDCARE MEDITECH CO., LTD. 2600 MISSION STREET SUITE 100 San Marino, CA 91108 |
| Contact | Jimmy Wu |
| Correspondent | Jimmy Wu SHENZHEN GOLDCARE MEDITECH CO., LTD. 2600 MISSION STREET SUITE 100 San Marino, CA 91108 |
| Product Code | HEX |
| CFR Regulation Number | 884.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-01 |
| Decision Date | 2013-09-18 |
| Summary: | summary |