The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Ge Discovery St System.
Device ID | K041220 |
510k Number | K041220 |
Device Name: | GE DISCOVERY ST SYSTEM |
Classification | System, Tomography, Computed, Emission |
Applicant | GE MEDICAL SYSTEMS P.O. 414 Milwaukee, WI 53188 |
Contact | David Duersteler |
Correspondent | David Duersteler GE MEDICAL SYSTEMS P.O. 414 Milwaukee, WI 53188 |
Product Code | KPS |
CFR Regulation Number | 892.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-05-10 |
Decision Date | 2004-06-15 |
Summary: | summary |