The following data is part of a premarket notification filed by Pausch Corp. with the FDA for Cs2000 & Cs2000 Tomo.
| Device ID | K973834 |
| 510k Number | K973834 |
| Device Name: | CS2000 & CS2000 TOMO |
| Classification | System, X-ray, Tomographic |
| Applicant | PAUSCH CORP. 808 SHREWSBURY AVE. Tenton Falls, NJ 07724 |
| Contact | Kenneth Tice |
| Correspondent | Kenneth Tice PAUSCH CORP. 808 SHREWSBURY AVE. Tenton Falls, NJ 07724 |
| Product Code | IZF |
| CFR Regulation Number | 892.1740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-08 |
| Decision Date | 1998-04-30 |