The following data is part of a premarket notification filed by Instrumentarium Imaging, Inc. with the FDA for Instrumentarium Mega4.
| Device ID | K912963 |
| 510k Number | K912963 |
| Device Name: | INSTRUMENTARIUM MEGA4 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | INSTRUMENTARIUM IMAGING, INC. 300 WEST EDGERTON AVE. Milwaukee, WI 53207 -6025 |
| Contact | Richard Halbach,ph.d |
| Correspondent | Richard Halbach,ph.d INSTRUMENTARIUM IMAGING, INC. 300 WEST EDGERTON AVE. Milwaukee, WI 53207 -6025 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-08 |
| Decision Date | 1991-09-30 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() INSTRUMENTARIUM MEGA4 74152266 1725173 Dead/Cancelled |
INSTRUMENTARIUM OY 1991-03-25 |