The following data is part of a premarket notification filed by Innovative Magnetic Resonance Imaging Systems Inc. with the FDA for Neuro Ii.
| Device ID | K002964 |
| 510k Number | K002964 |
| Device Name: | NEURO II |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | INNOVATIVE MAGNETIC RESONANCE IMAGING SYSTEMS INC. 11605 HITCHING POST LN. Rockville, MD 20852 |
| Contact | Joel S Faden |
| Correspondent | Joel S Faden INNOVATIVE MAGNETIC RESONANCE IMAGING SYSTEMS INC. 11605 HITCHING POST LN. Rockville, MD 20852 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-22 |
| Decision Date | 2000-12-19 |