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 |