The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Dtv-411op.
| Device ID | K870869 |
| 510k Number | K870869 |
| Device Name: | DTV-411OP |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
| Contact | Gary L Pembroke |
| Correspondent | Gary L Pembroke ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-03 |
| Decision Date | 1987-05-01 |