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FDA 510(k)

Fetal EchoScan (v1.1)

K-Number: K251071 · 2025-05-02

ApplicantBrightheart
Decision Date2025-05-02
Product CodePOK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Fetal EchoScan (v1.1) is a medical device manufactured by Brightheart. It received FDA 510(k) clearance on 2025-05-02 under approval number K251071. The device is classified under product code POK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fetal EchoScan (v1.1)?

Fetal EchoScan (v1.1) is a medical device that received FDA 510(k) clearance on 2025-05-02. It is manufactured by Brightheart. The 510(k) number is K251071.

When was Fetal EchoScan (v1.1) approved by the FDA?

Fetal EchoScan (v1.1) received FDA 510(k) clearance on 2025-05-02, under approval number K251071.

What company makes Fetal EchoScan (v1.1)?

Fetal EchoScan (v1.1) is manufactured by Brightheart.

What is the FDA product code for Fetal EchoScan (v1.1)?

The FDA product code for Fetal EchoScan (v1.1) is POK.

Other Devices by Brightheart

K242342Fetal EchoScan K252294Fetal EchoScan (v1.2) K251456BrightHeart View Classifier K243684BrightHeart View Classifier

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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