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FDA 510(k)

Dosimetry Check Version 5 Release 1

K-Number: K162577 · 2016-11-18

ApplicantMath Resolutions, LLC
Decision Date2016-11-18
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Dosimetry Check Version 5 Release 1 is the device name listed in this FDA 510(k) record. The listed applicant is Math Resolutions, LLC. It received FDA 510(k) clearance on 2016-11-18 under 510(k) number K162577. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dosimetry Check Version 5 Release 1?

Dosimetry Check Version 5 Release 1 is a medical device that received FDA 510(k) clearance on 2016-11-18. The listed applicant is Math Resolutions, LLC. The 510(k) number is K162577.

When did Dosimetry Check Version 5 Release 1 receive FDA 510(k) clearance?

Dosimetry Check Version 5 Release 1 received FDA 510(k) clearance on 2016-11-18, under 510(k) number K162577.

Who is the listed applicant for Dosimetry Check Version 5 Release 1?

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

What is the FDA product code for Dosimetry Check Version 5 Release 1?

The FDA product code for Dosimetry Check Version 5 Release 1 is IYE.

Related Devices (Code: IYE)

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.

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