DoseCHECK
Accelerator, Linear, Medical
Sun Nuclear Corporation
The following data is part of a premarket notification filed by Sun Nuclear Corporation with the FDA for Dosecheck.
Pre-market Notification Details
| Device ID | K161946 |
| 510k Number | K161946 |
| Device Name: | DoseCHECK |
| Classification | Accelerator, Linear, Medical |
| Applicant | Sun Nuclear Corporation 3275 Suntree Blvd. Melbourne, FL 32940 |
| Contact | Rene' Hardee |
| Correspondent | Rene' Hardee Sun Nuclear Corporation 3275 Suntree Blvd. Melbourne, FL 32940 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-15 |
| Decision Date | 2016-09-16 |
| Summary: | summary |
Trademark Results [DoseCHECK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DOSECHECK 86954867 not registered Dead/Abandoned |
Tripati, Arvita 2016-03-28 |
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