The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Pmi100 Video Imager.
| Device ID | K925220 |
| 510k Number | K925220 |
| Device Name: | PMI100 VIDEO IMAGER |
| Classification | Camera, Multi Format, Radiological |
| Applicant | HERAEUS KULZER, INC. 1 RAMLAND RD. Orangeburg, NY 10962 |
| Contact | Mark G Kalafut |
| Correspondent | Mark G Kalafut HERAEUS KULZER, INC. 1 RAMLAND RD. Orangeburg, NY 10962 |
| Product Code | LMC |
| CFR Regulation Number | 892.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-16 |
| Decision Date | 1993-05-20 |