Last synced on 27 June 2025 at 11:06 pm

Fetal EchoScan (v1.1)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K251071
510(k) Type
Special
Applicant
BrightHeart
Country
France
FDA Decision
Substantially Equivalent
Decision Date
5/2/2025
Days to Decision
25 days
Submission Type
Summary

Fetal EchoScan (v1.1)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K251071
510(k) Type
Special
Applicant
BrightHeart
Country
France
FDA Decision
Substantially Equivalent
Decision Date
5/2/2025
Days to Decision
25 days
Submission Type
Summary