Device Classification Name |
ventilatory effort recorder
|
510(k) Number |
K151433 |
Device Name |
AUDICOR CA300/CC100 Analyzer with SDB |
Applicant |
INOVISE MEDICAL, INC. |
8770 SW NIMBUS AVENUE |
SUITE D |
beaverton,
OR
97008
|
|
Applicant Contact |
earl anderson |
Correspondent |
INOVISE MEDICAL, INC. |
8770 SW NIMBUS AVENUE |
SUITE D |
beaverton,
OR
97008
|
|
Correspondent Contact |
earl anderson |
Regulation Number | 868.2375
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/28/2015 |
Decision Date | 03/18/2016 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|