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FDA 510(k)

SmartChest

K-Number: K232410 · 2024-05-10

ApplicantMilvue
Decision Date2024-05-10
Product CodeQFM
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SmartChest is a medical device manufactured by Milvue. It received FDA 510(k) clearance on 2024-05-10 under approval number K232410. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SmartChest?

SmartChest is a medical device that received FDA 510(k) clearance on 2024-05-10. It is manufactured by Milvue. The 510(k) number is K232410.

When was SmartChest approved by the FDA?

SmartChest received FDA 510(k) clearance on 2024-05-10, under approval number K232410.

What company makes SmartChest?

SmartChest is manufactured by Milvue.

What is the FDA product code for SmartChest?

The FDA product code for SmartChest is QFM.

Other Devices by Milvue

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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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