The following data is part of a premarket notification filed by Ferguson Medical with the FDA for Targobeam.
Device ID | K970819 |
510k Number | K970819 |
Device Name: | TARGOBEAM |
Classification | System, X-ray, Tomography, Computed |
Applicant | FERGUSON MEDICAL 3407 BAY AVE. Chico, CA 95973 -8619 |
Contact | Frank Ferguson |
Correspondent | Frank Ferguson FERGUSON MEDICAL 3407 BAY AVE. Chico, CA 95973 -8619 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-03-05 |
Decision Date | 1997-07-14 |
Summary: | summary |