The following data is part of a premarket notification filed by General Electric Co. with the FDA for Ct 9000.
Device ID | K843927 |
510k Number | K843927 |
Device Name: | CT 9000 |
Classification | System, X-ray, Tomography, Computed |
Applicant | GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
Contact | Howard Ii |
Correspondent | Howard Ii GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-05 |
Decision Date | 1984-12-17 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CT 9000 75098025 2069299 Live/Registered |
LIEBEL-FLARSHEIM COMPANY 1996-05-02 |