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 the device name listed in this FDA 510(k) record. The listed applicant is Milvue. It received FDA 510(k) clearance on 2024-05-10 under 510(k) 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. The listed applicant is Milvue. The 510(k) number is K232410.

When did SmartChest receive FDA 510(k) clearance?

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

Who is the listed applicant for SmartChest?

The FDA 510(k) record lists Milvue as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SmartChest?

The FDA product code for SmartChest is QFM.

Other records listing Milvue as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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