The following data is part of a premarket notification filed by 3m Medical Products Group with the FDA for 3m Color Laser Imager, Model 979.
Device ID | K923222 |
510k Number | K923222 |
Device Name: | 3M COLOR LASER IMAGER, MODEL 979 |
Classification | Camera, Multi Format, Radiological |
Applicant | 3M MEDICAL PRODUCTS GROUP 3M CENTER, BLDG. 275-3E-08 St. Paul, MN 55144 -1000 |
Contact | John A Gravelle |
Correspondent | John A Gravelle 3M MEDICAL PRODUCTS GROUP 3M CENTER, BLDG. 275-3E-08 St. Paul, MN 55144 -1000 |
Product Code | LMC |
CFR Regulation Number | 892.2040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-01 |
Decision Date | 1992-09-30 |