Device Classification Name |
Ventilatory Effort Recorder
|
510(k) Number |
K182618 |
Device Name |
SleepImage System |
Applicant |
MyCardio, LLC dba SleepImage. |
3513 Brighton Blvd, Suite 530 |
Denver,
CO
80216
|
|
Applicant Contact |
Robert Schueppert |
Correspondent |
MyCardio, LLC dba SleepImage. |
3513 Brighton Blvd, Suite 530 |
Denver,
CO
80216
|
|
Correspondent Contact |
Robert Schueppert |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 09/24/2018 |
Decision Date | 08/14/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|