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FDA 510(k)

LIFESCREEN APNEA

K-Number: K042745 · 2005-01-19

ApplicantDel Mar Reynolds Medical, Inc.
Decision Date2005-01-19
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LIFESCREEN APNEA is the device name listed in this FDA 510(k) record. The listed applicant is Del Mar Reynolds Medical, Inc.. It received FDA 510(k) clearance on 2005-01-19 under 510(k) number K042745. 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 LIFESCREEN APNEA?

LIFESCREEN APNEA is a medical device that received FDA 510(k) clearance on 2005-01-19. The listed applicant is Del Mar Reynolds Medical, Inc.. The 510(k) number is K042745.

When did LIFESCREEN APNEA receive FDA 510(k) clearance?

LIFESCREEN APNEA received FDA 510(k) clearance on 2005-01-19, under 510(k) number K042745.

Who is the listed applicant for LIFESCREEN APNEA?

The FDA 510(k) record lists Del Mar Reynolds Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIFESCREEN APNEA?

The FDA product code for LIFESCREEN APNEA is MNR.

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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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