The following data is part of a premarket notification filed by Instrumentarium Corp. with the FDA for Instrumentarium Ulf Mr Imaging System Model 110h.
| Device ID | K883649 |
| 510k Number | K883649 |
| Device Name: | INSTRUMENTARIUM ULF MR IMAGING SYSTEM MODEL 110H |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | INSTRUMENTARIUM CORP. 1120 G. STREET, N.W. Washington, DC 20005 |
| Contact | Robert A Dormer |
| Correspondent | Robert A Dormer INSTRUMENTARIUM CORP. 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 | 1988-08-29 |
| Decision Date | 1988-10-19 |