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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 the device name listed in this FDA 510(k) record. The listed applicant is Gleamer Sas. It received FDA 510(k) clearance on 2025-02-27 under 510(k) 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. The listed applicant is Gleamer Sas. The 510(k) number is K241620.

When did ChestView US receive FDA 510(k) clearance?

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

Who is the listed applicant for ChestView US?

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

What is the FDA product code for ChestView US?

The FDA product code for ChestView US is MYN.

Other records listing Gleamer Sas 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.

K241593BoneMetrics (US)

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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.

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