CardioGraphe
System, X-ray, Tomography, Computed
Arineta Ltd.
The following data is part of a premarket notification filed by Arineta Ltd. with the FDA for Cardiographe.
Pre-market Notification Details
| Device ID | K213465 |
| 510k Number | K213465 |
| Device Name: | CardioGraphe |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Arineta Ltd. 15 Halamish Street Caesarea, IL 3088900 |
| Contact | Tanya Shalem |
| Correspondent | Tanya Shalem Arineta Ltd. 15 Halamish Street Caesarea, IL 3088900 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-28 |
| Decision Date | 2022-12-02 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016484021 | K213465 | 000 |
| 07290016484014 | K213465 | 000 |
Trademark Results [CardioGraphe]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CARDIOGRAPHE 87373787 not registered Dead/Abandoned |
General Electric Company 2017-03-16 |
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