The following data is part of a premarket notification filed by Infimed, Inc. with the FDA for Ql Multipulse 2048.
| Device ID | K933299 |
| 510k Number | K933299 |
| Device Name: | QL MULTIPULSE 2048 |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | INFIMED, INC. 121 METROPOLITAN DR. Liverpool, NY 13088 |
| Contact | Noreen Reagan |
| Correspondent | Noreen Reagan INFIMED, INC. 121 METROPOLITAN DR. Liverpool, NY 13088 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-07 |
| Decision Date | 1993-11-03 |