The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Ge Discovery St.
Device ID | K041543 |
510k Number | K041543 |
Device Name: | GE DISCOVERY ST |
Classification | System, Tomography, Computed, Emission |
Applicant | GE HEALTHCARE 3000 N. GRANDVIEW BLVD Waukesha, WI 53188 |
Contact | Larry A Kroger |
Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
Product Code | KPS |
CFR Regulation Number | 892.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2004-06-08 |
Decision Date | 2004-06-22 |
Summary: | summary |