The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Millennium Mt And Millennium Mg Nuclear Medicine Systems.
| Device ID | K962738 |
| 510k Number | K962738 |
| Device Name: | MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMS |
| Classification | System, Tomography, Computed, Emission |
| Applicant | GE MEDICAL SYSTEMS PO BOX 414 Milwaukee, WI 53201 |
| Contact | Larry A Kroger, Ph.d. |
| Correspondent | Larry A Kroger, Ph.d. GE MEDICAL SYSTEMS PO 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 | 1996-07-15 |
| Decision Date | 1996-10-10 |
| Summary: | summary |