The following data is part of a premarket notification filed by General Electric Co. with the FDA for Compax Model 40, 400, 400t.
Device ID | K884930 |
510k Number | K884930 |
Device Name: | COMPAX MODEL 40, 400, 400T |
Classification | Table, Radiographic, Non-tilting, Powered |
Applicant | GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
Contact | Kroger, Phd |
Correspondent | Kroger, Phd GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
Product Code | IZZ |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-11-25 |
Decision Date | 1988-12-22 |