The following data is part of a premarket notification filed by I.z.i. Corp. with the FDA for Mr Enhancer.
| Device ID | K994117 |
| 510k Number | K994117 |
| Device Name: | MR ENHANCER |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | I.Z.I. CORP. P.O. BOX 4321 Crofton, MD 21114 |
| Contact | E. J Smith |
| Correspondent | E. J Smith I.Z.I. CORP. P.O. BOX 4321 Crofton, MD 21114 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-06 |
| Decision Date | 2000-02-04 |