The following data is part of a premarket notification filed by Tempo Technology, Inc. with the FDA for Trimode Sp Dental Intra Oral X-ray.
| Device ID | K896963 |
| 510k Number | K896963 |
| Device Name: | TRIMODE SP DENTAL INTRA ORAL X-RAY |
| Classification | Unit, X-ray, Intraoral |
| Applicant | TEMPO TECHNOLOGY, INC. ROUTE 1, DOWELL RD. Columbia City, IN 46725 |
| Contact | Christopher E Dare |
| Correspondent | Christopher E Dare TEMPO TECHNOLOGY, INC. ROUTE 1, DOWELL RD. Columbia City, IN 46725 |
| Product Code | EAP |
| CFR Regulation Number | 872.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-15 |
| Decision Date | 1990-01-22 |