The following data is part of a premarket notification filed by Led Medical Diagnostics Inc. with the FDA for Velscope.
| Device ID | K060920 |
| 510k Number | K060920 |
| Device Name: | VELSCOPE |
| Classification | Diagnostic Light, Soft Tissue Detector |
| Applicant | LED MEDICAL DIAGNOSTICS INC. #201-15047 MARINE DR. White Rock, British Columbia, CA V4b 1c5 |
| Contact | David C Morgan |
| Correspondent | David C Morgan LED MEDICAL DIAGNOSTICS INC. #201-15047 MARINE DR. White Rock, British Columbia, CA V4b 1c5 |
| Product Code | NXV |
| CFR Regulation Number | 872.6350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-04 |
| Decision Date | 2006-04-27 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VELSCOPE 78510940 3169666 Live/Registered |
LED Medical Diagnostics, Inc. 2004-11-03 |