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FDA 510(k)

CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE

K-Number: K092003 · 2009-09-30

ApplicantMyCardio, LLC
Decision Date2009-09-30
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is MyCardio, LLC. It received FDA 510(k) clearance on 2009-09-30 under 510(k) number K092003. 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 CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE?

CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE is a medical device that received FDA 510(k) clearance on 2009-09-30. The listed applicant is MyCardio, LLC. The 510(k) number is K092003.

When did CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE receive FDA 510(k) clearance?

CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE received FDA 510(k) clearance on 2009-09-30, under 510(k) number K092003.

Who is the listed applicant for CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE?

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

What is the FDA product code for CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE?

The FDA product code for CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE is MNR.

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Related Devices (Code: 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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