The following data is part of a premarket notification filed by Hitachi Medical Systems America, Inc. with the FDA for Mrh-1500.
Device ID | K922846 |
510k Number | K922846 |
Device Name: | MRH-1500 |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | HITACHI MEDICAL SYSTEMS AMERICA, INC. 1963 CASE PKWY. Twinsburg, OH 44087 |
Contact | Jochen Rogers |
Correspondent | Jochen Rogers HITACHI MEDICAL SYSTEMS AMERICA, INC. 1963 CASE PKWY. Twinsburg, OH 44087 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-15 |
Decision Date | 1993-06-08 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MRH-1500 74490247 1879644 Dead/Cancelled |
Hitachi Medical Systems America, Inc. 1994-02-15 |