The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Modification To Ge Discovery Ls System.
Device ID | K040172 |
510k Number | K040172 |
Device Name: | MODIFICATION TO GE DISCOVERY LS SYSTEM |
Classification | System, Tomography, Computed, Emission |
Applicant | GE MEDICAL SYSTEMS P.O. BOX 414 Milwaukee, WI 53201 |
Contact | Larry A Kroger |
Correspondent | Larry A Kroger GE MEDICAL SYSTEMS P.O. BOX 414 Milwaukee, WI 53201 |
Product Code | KPS |
CFR Regulation Number | 892.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-01-26 |
Decision Date | 2004-04-07 |
Summary: | summary |