FDA 510(k) · SleepImage
K182618: SleepImage System (Mycardio, LLC Dba Sleepimage.)
Mycardio, LLC Dba Sleepimage. received FDA 510(k) K182618 for SleepImage System, with a decision date of Aug 14, 2019 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K182618 |
|---|---|
| Pathway | 510(k) |
| Applicant | Mycardio, LLC Dba Sleepimage. |
| Device name | SleepImage System |
| Product code | MNR: Ventilatory Effort Recorder |
| Regulation (21 CFR) | 868.2375 |
| Device class | Class 2 |
| Date received | Sep 24, 2018 |
| Decision date | Aug 14, 2019 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The SleepImage System is Software as a Medical Device (SaMD) that establishes sleep quality. The SleepImage System analyzes, displays and summarizes Electrocardiogram (ECG) or Plethysmogram (PLETH) data, typically collected during sleep, 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. MyCardio, LLC 8/13/2019
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
- K163696 SleepImage System (SleepImage)
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code MNR is "Ventilatory Effort Recorder", class 2, 21 CFR 868.2375.
Our labels for filtering: claim Sleep apnea, sensor Other. These are heuristics, not FDA fields.