Device Classification Name |
ventilatory effort recorder
|
510(k) Number |
K092003 |
Device Name |
CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE |
Applicant |
MyCardio, LLC |
11001 W. 120TH AVE. |
SUITE 200 |
BROOMFIELD,
CO
80021
|
|
Applicant Contact |
ROBERT SCHUEPPERT |
Correspondent |
MyCardio, LLC |
11001 W. 120TH AVE. |
SUITE 200 |
BROOMFIELD,
CO
80021
|
|
Correspondent Contact |
ROBERT SCHUEPPERT |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 07/02/2009 |
Decision Date | 09/30/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|