The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Impax 5000.
| Device ID | K934386 |
| 510k Number | K934386 |
| Device Name: | IMPAX 5000 |
| Classification | System, Digital Image Communications, Radiological |
| 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 | LMD |
| CFR Regulation Number | 892.2020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-08 |
| Decision Date | 1994-01-05 |