The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for Vacudap, Model 2000, 2001.
| Device ID | K974112 |
| 510k Number | K974112 |
| Device Name: | VACUDAP, MODEL 2000, 2001 |
| Classification | System, X-ray, Stationary |
| Applicant | VICTOREEN, INC. 6000 COCHRAN RD. Solon, OH 44139 -3395 |
| Contact | Linda S Nash |
| Correspondent | Linda S Nash VICTOREEN, INC. 6000 COCHRAN RD. Solon, OH 44139 -3395 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-31 |
| Decision Date | 1998-01-29 |
| Summary: | summary |