The following data is part of a premarket notification filed by General Electric Co. with the FDA for Compax 90/15e.
Device ID | K954356 |
510k Number | K954356 |
Device Name: | COMPAX 90/15E |
Classification | Table, Radiographic, Tilting |
Applicant | GENERAL ELECTRIC CO. P0 BOX 414 Milwaukee, WI |
Contact | Larry A Kroher |
Correspondent | Larry A Kroher GENERAL ELECTRIC CO. P0 BOX 414 Milwaukee, WI |
Product Code | IXR |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-09-18 |
Decision Date | 1995-10-07 |