The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Impax 3000.
| Device ID | K934832 |
| 510k Number | K934832 |
| Device Name: | IMPAX 3000 |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | HERAEUS KULZER, INC. 1 RAMLAND RD. Orangeburg, NY 10962 |
| Contact | Michael Sullivan |
| Correspondent | Michael Sullivan HERAEUS KULZER, INC. 1 RAMLAND RD. Orangeburg, NY 10962 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-08 |
| Decision Date | 1993-12-14 |