The following data is part of a premarket notification filed by Mri Devices Corp. with the FDA for Eloquence, Integrated Functional Imaging System.
| Device ID | K023130 |
| 510k Number | K023130 |
| Device Name: | ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MRI DEVICES CORP. 1515 PARAMOUNT DR. Waukesha, WI 53186 |
| Contact | William J Dinehart |
| Correspondent | William J Dinehart MRI DEVICES CORP. 1515 PARAMOUNT DR. Waukesha, WI 53186 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-20 |
| Decision Date | 2002-10-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838081758 | K023130 | 000 |