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FDA 510(k)

QFR (3.0)

K-Number: K243769 · 2025-04-04

ApplicantQfr Solutions BV
Decision Date2025-04-04
Product CodeQHA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QFR (3.0) is a medical device manufactured by Qfr Solutions BV. It received FDA 510(k) clearance on 2025-04-04 under approval number K243769. The device is classified under product code QHA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QFR (3.0)?

QFR (3.0) is a medical device that received FDA 510(k) clearance on 2025-04-04. It is manufactured by Qfr Solutions BV. The 510(k) number is K243769.

When was QFR (3.0) approved by the FDA?

QFR (3.0) received FDA 510(k) clearance on 2025-04-04, under approval number K243769.

What company makes QFR (3.0)?

QFR (3.0) is manufactured by Qfr Solutions BV.

What is the FDA product code for QFR (3.0)?

The FDA product code for QFR (3.0) is QHA.

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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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