CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE— 510(k) K092003

Name: FDA 510(k) clearance K092003
Creator: U.S. Food and Drug Administration
Published: 2009-09-30

Substantially Equivalent

MyCardio, LLC

FDA 510(k) clearance K092003 for CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE, Substantially Equivalent on 2009-09-30. Applicant: MyCardio, LLC. Device class: 2.

Clearance details

Applicant: MyCardio, LLC
Product code: Code MNR
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2009-07-02
Decision date: 2009-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Broomfield, CO, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.