The following data is part of a premarket notification filed by Magnetic Resonance Plus, Inc. with the FDA for Snr-3000 Upgrade Receiver Coils.
Device ID | K925597 |
510k Number | K925597 |
Device Name: | SNR-3000 UPGRADE RECEIVER COILS |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | MAGNETIC RESONANCE PLUS, INC. 5310 POWER INN RD. STE. D Sacramento, CA 95820 |
Contact | Robert L Domenick |
Correspondent | Robert L Domenick MAGNETIC RESONANCE PLUS, INC. 5310 POWER INN RD. STE. D Sacramento, CA 95820 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-04 |
Decision Date | 1993-10-07 |