Device Classification Name |
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
|
510(k) Number |
K121768 |
Device Name |
COSENSE |
Applicant |
Capnia, Inc. |
2445 FABER PLACE, STUITE 250 |
PALO ALTO,
CA
94303
|
|
Applicant Contact |
Julie Blacklock |
Correspondent |
Capnia, Inc. |
2445 FABER PLACE, STUITE 250 |
PALO ALTO,
CA
94303
|
|
Correspondent Contact |
Julie Blacklock |
Regulation Number | 868.1430
|
Classification Product Code |
|
Date Received | 06/15/2012 |
Decision Date | 10/31/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|