The following data is part of a premarket notification filed by Oldelft Corp. Of America with the FDA for Oldelft Digidelca.
| Device ID | K980296 |
| 510k Number | K980296 |
| Device Name: | OLDELFT DIGIDELCA |
| Classification | System, X-ray, Stationary |
| Applicant | OLDELFT CORP. OF AMERICA 9108 GUILFORD RD. Columbia, MD 21046 |
| Contact | Ernest King |
| Correspondent | Ernest King OLDELFT CORP. OF AMERICA 9108 GUILFORD RD. Columbia, MD 21046 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-27 |
| Decision Date | 1998-04-17 |
| Summary: | summary |