The following data is part of a premarket notification filed by Hitachi Medical Systems America, Inc. with the FDA for Mobile Mrp-7000.
Device ID | K920159 |
510k Number | K920159 |
Device Name: | MOBILE MRP-7000 |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | HITACHI MEDICAL SYSTEMS AMERICA, INC. 77 MILFORD RD. Hudson, OH 44236 |
Contact | Jochen Rogers |
Correspondent | Jochen Rogers HITACHI MEDICAL SYSTEMS AMERICA, INC. 77 MILFORD RD. Hudson, OH 44236 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-01-14 |
Decision Date | 1992-03-05 |