The following data is part of a premarket notification filed by Paragon Diagnostics, Inc. with the FDA for Immpulse System.
| Device ID | K834070 |
| 510k Number | K834070 |
| Device Name: | IMMPULSE SYSTEM |
| Classification | Fluorometer |
| Applicant | PARAGON DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JZT |
| CFR Regulation Number | 866.4520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-25 |
| Decision Date | 1984-03-23 |