The following data is part of a premarket notification filed by General Electric Co. with the FDA for Starcam 4000.
Device ID | K904174 |
510k Number | K904174 |
Device Name: | STARCAM 4000 |
Classification | Camera, Scintillation (gamma) |
Applicant | GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
Contact | Larry Kroger |
Correspondent | Larry 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 | 1990-09-10 |
Decision Date | 1991-01-04 |