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FDA 510(k)

BREATHKEY MODEL G10/BREATHKEY MODEL G30X

K-Number: K052804 · 2005-12-09

ApplicantOmega Point Systems, LLC
Decision Date2005-12-09
Product CodeDJZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BREATHKEY MODEL G10/BREATHKEY MODEL G30X is the device name listed in this FDA 510(k) record. The listed applicant is Omega Point Systems, LLC. It received FDA 510(k) clearance on 2005-12-09 under 510(k) number K052804. The device is classified under product code DJZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREATHKEY MODEL G10/BREATHKEY MODEL G30X?

BREATHKEY MODEL G10/BREATHKEY MODEL G30X is a medical device that received FDA 510(k) clearance on 2005-12-09. The listed applicant is Omega Point Systems, LLC. The 510(k) number is K052804.

When did BREATHKEY MODEL G10/BREATHKEY MODEL G30X receive FDA 510(k) clearance?

BREATHKEY MODEL G10/BREATHKEY MODEL G30X received FDA 510(k) clearance on 2005-12-09, under 510(k) number K052804.

Who is the listed applicant for BREATHKEY MODEL G10/BREATHKEY MODEL G30X?

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

What is the FDA product code for BREATHKEY MODEL G10/BREATHKEY MODEL G30X?

The FDA product code for BREATHKEY MODEL G10/BREATHKEY MODEL G30X is DJZ.

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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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