The following data is part of a premarket notification filed by Instrumentarium Corp. with the FDA for Instrumentarium Ulf Mr Imaging System.
| Device ID | K883621 |
| 510k Number | K883621 |
| Device Name: | INSTRUMENTARIUM ULF MR IMAGING SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | INSTRUMENTARIUM CORP. HYMAN, PHELPS & MCNAMARA, P.C. 1120 G STREET, N.W. Washington, DC 20005 |
| Contact | Robert Dormer |
| Correspondent | Robert Dormer INSTRUMENTARIUM CORP. HYMAN, PHELPS & MCNAMARA, P.C. 1120 G STREET, N.W. Washington, DC 20005 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-25 |
| Decision Date | 1988-11-10 |