The following data is part of a premarket notification filed by Aspen Laboratories, Inc. with the FDA for Rgb Camera System.
Device ID | K872661 |
510k Number | K872661 |
Device Name: | RGB CAMERA SYSTEM |
Classification | Camera, Television, Endoscopic, Without Audio |
Applicant | ASPEN LABORATORIES, INC. P.O. BOX 3936 Englewood, CO 80155 -3936 |
Contact | Johnson |
Correspondent | Johnson ASPEN LABORATORIES, INC. P.O. BOX 3936 Englewood, CO 80155 -3936 |
Product Code | FWF |
CFR Regulation Number | 878.4160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-07 |
Decision Date | 1987-07-21 |