The following data is part of a premarket notification filed by Cea America Corp. with the FDA for Singul-xr Rp Non Screen Med. Film.
| Device ID | K834611 |
| 510k Number | K834611 |
| Device Name: | SINGUL-XR RP NON SCREEN MED. FILM |
| Classification | Film, Radiographic |
| Applicant | CEA AMERICA CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IWZ |
| CFR Regulation Number | 892.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-20 |
| Decision Date | 1984-02-21 |