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FDA 510(k)

ChestView US

K-Number: K241620 · 2025-02-27

ApplicantGleamer Sas
Decision Date2025-02-27
Product CodeMYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ChestView US is a medical device manufactured by Gleamer Sas. It received FDA 510(k) clearance on 2025-02-27 under approval number K241620. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ChestView US?

ChestView US is a medical device that received FDA 510(k) clearance on 2025-02-27. It is manufactured by Gleamer Sas. The 510(k) number is K241620.

When was ChestView US approved by the FDA?

ChestView US received FDA 510(k) clearance on 2025-02-27, under approval number K241620.

What company makes ChestView US?

ChestView US is manufactured by Gleamer Sas.

What is the FDA product code for ChestView US?

The FDA product code for ChestView US is MYN.

Other Devices by Gleamer Sas

Related Devices (Code: MYN)

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.