The following data is part of a premarket notification filed by Ge Medical Systems F.i. Haifa with the FDA for Ge Quasar Nuclear Medicine System.
Device ID | K022960 |
510k Number | K022960 |
Device Name: | GE QUASAR NUCLEAR MEDICINE SYSTEM |
Classification | System, Tomography, Computed, Emission |
Applicant | GE MEDICAL SYSTEMS F.I. HAIFA 10 HAYOZMA ST. Tirat Hacarmel, IL 30200 |
Contact | Hemy Neuman |
Correspondent | Heinz Joerg Steneberg 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 | 2002-09-06 |
Decision Date | 2002-09-19 |
Summary: | summary |