FDA 510(k) Applications Submitted by Christophe Gardella
| FDA 510(k) Number | Submission Date | Device Name | Applicant |
|---|---|---|---|
| K251071 | 04/07/2025 | Fetal EchoScan (v1.1) | BrightHeart |
| K251456 | 05/12/2025 | BrightHeart View Classifier | BrightHeart |
| K242342 | 08/07/2024 | Fetal EchoScan | BrightHeart |
| K243684 | 11/29/2024 | BrightHeart View Classifier | BrightHeart |
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