The following data is part of a premarket notification filed by Pausch Corp. with the FDA for Combi Elevator-2 & Combi Elevator-2 Tomo.
| Device ID | K973864 |
| 510k Number | K973864 |
| Device Name: | COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO |
| Classification | System, X-ray, Tomographic |
| Applicant | PAUSCH CORP. 808 SHREWSBURY AVE. Tenton Falls, NJ 07724 |
| Contact | Kenneth J H. Rice |
| Correspondent | Kenneth J H. Rice PAUSCH CORP. 808 SHREWSBURY AVE. Tenton Falls, NJ 07724 |
| Product Code | IZF |
| Subsequent Product Code | IYB |
| Subsequent Product Code | IZZ |
| CFR Regulation Number | 892.1740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-09 |
| Decision Date | 1998-06-17 |