# Mycardio, LLC Dba Sleepimage.

- Location (FDA's records): Broomfield, CO
- FDA decisions: 2 (2017–2019): 2 510(k) clearances
- Product codes: MNR (2)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 3 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- MyCardio, LLC: 1 (https://510kreport.com/company/mycardio)

## Firms that cite its devices most
- Ensodata, Inc.: 1 (https://510kreport.com/company/ensodata)
- Wesper, Inc.: 1 (https://510kreport.com/company/wesper)

## Its most-cited devices
- K182618: SleepImage System (2019), cited by 2
- K163696: SleepImage System (2017), cited by 1

## Recent decisions
- K182618: SleepImage System (Aug 14, 2019)
- K163696: SleepImage System (Oct 13, 2017)

Source page: https://510kreport.com/company/mycardio-dba-sleepimage