MYCARDIO

FDA Device Registration & Listing · Denver, CO, US · Registration 3009498109

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009498109
FEI Number
3009498109
Entity Name
MYCARDIO
City/State/Country
Denver, CO, US
Establishment Address
3200 E Cherry Creek South Dr, Suite 540, Denver, CO 80209, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
MyCardio (Owner Number: 10039503)
Owner / Operator Contact Address
3200 E Cherry Creek South Dr, Suite 540, Denver, CO 80209, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K182618
PMA Number
N/A

All Registered Proprietary Names

SleepImage System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2021-09-03

Official Correspondent

Bogi Palsson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MyCardio
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K082968 Apneicare, LLC APNEICARE CONNECTION CENTER/INTERNET ANALYSIS 2009-01-02

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-2022 NOX MEDICAL Keldnaholt Reykjavik Iceland 2
Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009498109. Last updated year: 2026. Please use registration number 3009498109 when referencing this establishment in official correspondence.
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