The following data is part of a premarket notification filed by Siemens Corp. with the FDA for Pandoros 1200a.
| Device ID | K811149 |
| 510k Number | K811149 |
| Device Name: | PANDOROS 1200A |
| Classification | System, X-ray, Angiographic |
| Applicant | SIEMENS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-27 |
| Decision Date | 1981-06-09 |