Fetal EchoScan— 510(k) K242342
Substantially EquivalentBrightheart
FDA 510(k) clearance K242342 for Fetal EchoScan, Substantially Equivalent on 2024-11-14. Applicant: Brightheart. Device class: 2.
Clearance details
- Applicant
- Brightheart
- Product code
- Code POK
- Device class
- Class 2
- Regulation
- 21 CFR 892.2060
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Paris, FR
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