The following data is part of a premarket notification filed by Videolabs, Inc. with the FDA for Videolabs Medcam Proplus Video Camera And Integral Light Source.
Device ID | K000229 |
510k Number | K000229 |
Device Name: | VIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOURCE |
Classification | Light Source, Fiberoptic, Routine |
Applicant | VIDEOLABS, INC. 2530 PENNSYLVANIA AVE. Saint Louis Park, MN 55426 |
Contact | Frank B Freedman |
Correspondent | Frank B Freedman VIDEOLABS, INC. 2530 PENNSYLVANIA AVE. Saint Louis Park, MN 55426 |
Product Code | FCW |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-01-27 |
Decision Date | 2000-03-21 |