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 |