Esteya
System, Therapeutic, X-ray
Nucletron B.V.
The following data is part of a premarket notification filed by Nucletron B.v. with the FDA for Esteya.
Pre-market Notification Details
| Device ID | K213942 |
| 510k Number | K213942 |
| Device Name: | Esteya |
| Classification | System, Therapeutic, X-ray |
| Applicant | Nucletron B.V. 3900 Ax Veenendaal, P.O. Box 930, Waardgelder 1 Veenendaal, NL 3905 TH |
| Contact | Kiran Jose |
| Correspondent | Kiran Jose Nucletron B.V. 3900 Ax Veenendaal, P.O. Box 930, Waardgelder 1 Veenendaal, NL 3905 TH |
| Product Code | JAD |
| CFR Regulation Number | 892.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-17 |
| Decision Date | 2022-01-11 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08717213057760 | K213942 | 000 |
Trademark Results [Esteya]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ESTEYA 79116060 4366437 Live/Registered |
Nucletron Operations B.V. 2012-05-21 |
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