MYOLIGHT
System, Tomography, Computed, Emission
GE MEDICAL SYSTEMS F.I. HAIFA
The following data is part of a premarket notification filed by Ge Medical Systems F.i. Haifa with the FDA for Myolight.
Pre-market Notification Details
| Device ID | K033874 |
| 510k Number | K033874 |
| Device Name: | MYOLIGHT |
| Classification | System, Tomography, Computed, Emission |
| Applicant | GE MEDICAL SYSTEMS F.I. HAIFA 4 HAYOZMA ST. Tirat Hacarmel, IL 30200 |
| Contact | Laurence Bigio |
| Correspondent | Chantel Carson UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-12-15 |
| Decision Date | 2003-12-30 |
| Summary: | summary |
Trademark Results [MYOLIGHT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MYOLIGHT 78316475 not registered Dead/Abandoned |
General Electric Company 2003-10-21 |
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