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FDA 510(k)

APNEACHECK

K-Number: K022294 · 2003-04-25

ApplicantIm Systems
Decision Date2003-04-25
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

APNEACHECK is the device name listed in this FDA 510(k) record. The listed applicant is Im Systems. It received FDA 510(k) clearance on 2003-04-25 under 510(k) number K022294. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APNEACHECK?

APNEACHECK is a medical device that received FDA 510(k) clearance on 2003-04-25. The listed applicant is Im Systems. The 510(k) number is K022294.

When did APNEACHECK receive FDA 510(k) clearance?

APNEACHECK received FDA 510(k) clearance on 2003-04-25, under 510(k) number K022294.

Who is the listed applicant for APNEACHECK?

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

What is the FDA product code for APNEACHECK?

The FDA product code for APNEACHECK is MNR.

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Related Devices (Code: MNR)

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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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