The following data is part of a premarket notification filed by Mycardio, Llc Dba Sleepimage. with the FDA for Sleepimage System.
| Device ID | K182618 |
| 510k Number | K182618 |
| Device Name: | SleepImage System |
| Classification | Ventilatory Effort Recorder |
| Applicant | MyCardio, LLC Dba SleepImage. 3513 Brighton Blvd, Suite 530 Denver, CO 80216 |
| Contact | Robert Schueppert |
| Correspondent | Robert Schueppert MyCardio, LLC Dba SleepImage. 3513 Brighton Blvd, Suite 530 Denver, CO 80216 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-24 |
| Decision Date | 2019-08-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B315SLEEPIMAGESYSTEMD8 | K182618 | 000 |