The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Video Colposcope.
| Device ID | K151878 |
| 510k Number | K151878 |
| Device Name: | Video Colposcope |
| Classification | Colposcope (and Colpomicroscope) |
| Applicant | EDAN INSTRUMENTS, INC. 3/F- B, Nanshan Medical Equipments Park Nanhai Rd 1019# Shenzhen, CN 518067 |
| Contact | Queena Chen |
| Correspondent | Doug Worth EDAN MEDICAL 1200 CROSSMAN AVE, SUITE 200 Sunnyvale, CA 94086 |
| Product Code | HEX |
| CFR Regulation Number | 884.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-09 |
| Decision Date | 2015-12-01 |
| Summary: | summary |