The following data is part of a premarket notification filed by Marconi Medical Systems, Inc. with the FDA for Boluspro Ultra.
| Device ID | K002005 |
| 510k Number | K002005 |
| Device Name: | BOLUSPRO ULTRA |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | MARCONI MEDICAL SYSTEMS, INC. 5595 MINER RD. Highland Heights, OH 44143 |
| Contact | Robert L Turocy |
| Correspondent | Robert L Turocy MARCONI MEDICAL SYSTEMS, INC. 5595 MINER RD. Highland Heights, OH 44143 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-03 |
| Decision Date | 2000-09-22 |