The following data is part of a premarket notification filed by Instrumentarium Corp. with the FDA for Instrumentarium Ulf Mr Imaging System Version 110.
| Device ID | K883650 |
| 510k Number | K883650 |
| Device Name: | INSTRUMENTARIUM ULF MR IMAGING SYSTEM VERSION 110 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | INSTRUMENTARIUM CORP. C/O BIOMETRIC RESEARCH INSTITU 1401 WILSON BLVD., SUITE 400 Arlington, VA 22209 |
| Contact | Frank L Hurley |
| Correspondent | Frank L Hurley INSTRUMENTARIUM CORP. C/O BIOMETRIC RESEARCH INSTITU 1401 WILSON BLVD., SUITE 400 Arlington, VA 22209 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-29 |
| Decision Date | 1988-09-16 |