Data / Medical devices / United States / Mycardio
Mycardio: FDA-registered device maker in Denver, CO, United States, 1 510(k) clearance
Mycardio is registered with the FDA (registration 3009498109) in Denver, CO, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 14, 2019. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3009498109
- Address
- 3200 E Cherry Creek South Dr Suite 540, Denver, CO, United States, 80209
- Owner or operator
- MyCardio (10039503)
- Roles
- Manufacturer
- First device listed
- September 3, 2021
- Registered through
- 2027
- Brand names listed
- SleepImage System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Ventilatory Effort Recorder | MNR | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 14, 2019 | K182618 | SleepImage System | MNR | Substantially Equivalent | Mycardio, LLC Dba Sleepimage. | accessdata.fda.gov |
Compare with other makers
Updated August 14, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.