3DVH
Accelerator, Linear, Medical
SUN NUCLEAR CORPORATION
The following data is part of a premarket notification filed by Sun Nuclear Corporation with the FDA for 3dvh.
Pre-market Notification Details
| Device ID | K131862 |
| 510k Number | K131862 |
| Device Name: | 3DVH |
| Classification | Accelerator, Linear, Medical |
| Applicant | SUN NUCLEAR CORPORATION 3275 Suntree Blvd Melbourne, FL 32940 |
| Contact | Jeff Kapatoes |
| Correspondent | Jeff Kapatoes 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 | 2013-06-24 |
| Decision Date | 2013-08-21 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B016121200000 | K131862 | 000 |
Trademark Results [3DVH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 3DVH 85136765 4051011 Live/Registered |
Sun Nuclear Corp. 2010-09-23 |
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