Fetal EchoScan— 510(k) K242342

Substantially Equivalent

Brightheart

FDA 510(k) clearance K242342 for Fetal EchoScan, Substantially Equivalent on 2024-11-14. Applicant: Brightheart.

Clearance details

Applicant: Brightheart
Product code: Code POK
Advisory panel: Radiology
Date received: 2024-08-07
Decision date: 2024-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paris, FR

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