The following data is part of a premarket notification filed by Sicel Technologies Inc with the FDA for Onedose Patient Dosimetry System.
| Device ID | K040687 |
| 510k Number | K040687 |
| Device Name: | ONEDOSE PATIENT DOSIMETRY SYSTEM |
| Classification | Accelerator, Linear, Medical |
| Applicant | SICEL TECHNOLOGIES INC 3800 GATEWAY CENTRE BLVD. SUITE 308 Morrisville, NC 27560 |
| Contact | Tammy B Carrea |
| Correspondent | Tammy B Carrea SICEL TECHNOLOGIES INC 3800 GATEWAY CENTRE BLVD. SUITE 308 Morrisville, NC 27560 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-16 |
| Decision Date | 2004-06-25 |
| Summary: | summary |