The following data is part of a premarket notification filed by Mycardio, Llc with the FDA for Cpc Sleep Data Recorder, Model M1, And Application Software.
| Device ID | K092003 |
| 510k Number | K092003 |
| Device Name: | CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE |
| Classification | Ventilatory Effort Recorder |
| Applicant | MyCardio, LLC 11001 W. 120TH AVE. SUITE 200 Broomfield, CO 80021 |
| Contact | Robert Schueppert |
| Correspondent | Robert Schueppert MyCardio, LLC 11001 W. 120TH AVE. SUITE 200 Broomfield, CO 80021 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-02 |
| Decision Date | 2009-09-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B315SLEEPIMAGECOM0 | K092003 | 000 |