SleepImage System
MyCardio, LLC Dba SleepImage.
MYCARDIO
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3009498109 | 3009498109 | MYCARDIO | 1 | N | 2026-01-01 | 3200 E Cherry Creek South Dr Suite 540 Denver CO US 80209 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 137376 | 1457331655 | K182618 | SleepImage System | MNR | 2019-08-14 |
| 137376 | 1986905424 | K092003 | CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE | MNR | 2009-09-30 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| MNR | 2 | 2019-08-14 |
PMN#
SleepImage System
MyCardio, LLC Dba SleepImage.
CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE
MyCardio, LLC
GUDID#
SleepImage - Web based software
2017-01-17
SleepImage System - The SleepImage System is Software as a Medical Device (SaMD) that establishes sleep quality. The SleepImage Systemanalyzes, displays and summarizes Electrocardiogram (ECG) or Plethysmogram (PLETH) data, typically collected duringsleep, that is intended for use by or on the order of a Healthcare Professional to aid in the evaluation of sleep disorders,where it may inform or drive clinical management for children, adolescents and adults.The SleepImage Apnea Hypopnea Index (sAHI), presented when oximeter data is available, is intended to aid healthcareprofessionals in diagnosis and management of sleep disordered breathing.The SleepImage System output is not intended to be interpreted or clinical action taken without consultation of a qualifiedhealthcare professional.
2023-11-10