Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K162343 |
Device Name |
Westmed Gas Sampling Cannula with O2 delivery |
Applicant |
WESTMED, INC. |
5580 S NOGALES HWY |
TUCSON,
AZ
85706
|
|
Applicant Contact |
DIANA UPP |
Correspondent |
WESTMED, INC. |
5580 S NOGALES HWY |
TUCSON,
AZ
85706
|
|
Correspondent Contact |
PAUL DRYDEN |
Regulation Number | 868.1400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/22/2016 |
Decision Date | 12/14/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|