FDA 510(k) · SleepImage
K092003: CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE (MyCardio, LLC)
MyCardio, LLC received FDA 510(k) K092003 for CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE, with a decision date of Sep 30, 2009 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K092003 |
|---|---|
| Pathway | 510(k) |
| Applicant | MyCardio, LLC |
| Device name | CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE |
| Product code | MNR: Ventilatory Effort Recorder |
| Regulation (21 CFR) | 868.2375 |
| Device class | Class 2 |
| Date received | Jul 2, 2009 |
| Decision date | Sep 30, 2009 |
| 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
We could not extract the indications for this record. Check the FDA record for its summary or statement.
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.
Later records that cite K092003
- K163696 SleepImage System (SleepImage, Oct 13, 2017, MNR)
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.