The following data is part of a premarket notification filed by Mycardio, Llc Dba Sleepimage. with the FDA for Sleepimage System.
| Device ID | K163696 |
| 510k Number | K163696 |
| Device Name: | SleepImage System |
| Classification | Ventilatory Effort Recorder |
| Applicant | MyCardio, LLC Dba SleepImage. 370 Interlocken Blvd. Suite 650 Broomfield, CO 80021 |
| Contact | Robert Schueppert |
| Correspondent | Robert Schueppert MyCardio, LLC Dba SleepImage. 370 Interlocken Blvd. Suite 650 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 | 2016-12-29 |
| Decision Date | 2017-10-13 |
| Summary: | summary |