Device Classification Name |
Ventilatory Effort Recorder
|
510(k) Number |
K131883 |
Device Name |
AUDICOR CPAM WITH SDB (ACCELEROMETER BASED) |
Applicant |
INOVISE MEDICAL, INC. |
8770 SW NIMBUS AVENUE |
SUITE D |
BEAVERTON,
OR
97008 -7196
|
|
Applicant Contact |
EARL ANDERSON |
Correspondent |
INOVISE MEDICAL, INC. |
8770 SW NIMBUS AVENUE |
SUITE D |
BEAVERTON,
OR
97008 -7196
|
|
Correspondent Contact |
EARL ANDERSON |
Regulation Number | 868.2375
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/25/2013 |
Decision Date | 04/11/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|