Device Classification Name |
analyzer, gas, carbon-dioxide, gaseous-phase
|
510(k) Number |
K123043 |
Device Name |
IRMA C02 MODEL 200101; IRMA AX 200601 |
Applicant |
PHASEIN AB |
404 WILLIAMSON ST. |
SUITE 402 |
MADISON,
WI
53703
|
|
Applicant Contact |
DAVID WEISSBURG |
Correspondent |
PHASEIN AB |
404 WILLIAMSON ST. |
SUITE 402 |
MADISON,
WI
53703
|
|
Correspondent Contact |
DAVID WEISSBURG |
Regulation Number | 868.1400
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/28/2012 |
Decision Date | 10/25/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|