The following data is part of a premarket notification filed by General Electric Co. with the FDA for Unix-link.
Device ID | K926550 |
510k Number | K926550 |
Device Name: | UNIX-LINK |
Classification | Camera, Scintillation (gamma) |
Applicant | GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
Contact | Larry A Kroger |
Correspondent | Larry A Kroger GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
Product Code | IYX |
CFR Regulation Number | 892.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-31 |
Decision Date | 1993-03-18 |