The following data is part of a premarket notification filed by Goldway Us, Inc. with the FDA for Goldway Digital Video Colposcope Imaging System, Model #slc-2000.
| Device ID | K021153 |
| 510k Number | K021153 |
| Device Name: | GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC-2000 |
| Classification | Colposcope (and Colpomicroscope) |
| Applicant | GOLDWAY US, INC. 12 SOUTH FIRST STREET, SUITE 1205 San Jose, CA 95113 |
| Contact | Y. Justin Chen |
| Correspondent | Y. Justin Chen GOLDWAY US, INC. 12 SOUTH FIRST STREET, SUITE 1205 San Jose, CA 95113 |
| Product Code | HEX |
| CFR Regulation Number | 884.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-10 |
| Decision Date | 2003-02-10 |
| Summary: | summary |