Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K143469 |
Device Name |
SOFTECH Plus ETCO2 Cannula |
Applicant |
TELEFLEX MEDICAL, INC. |
2917 WECK DRIVE |
RESEARCH TRIANGLE,
NC
27709
|
|
Applicant Contact |
Brian Gall |
Correspondent |
TELEFLEX MEDICAL, INC. |
2917 WECK DRIVE |
RESEARCH TRIANGLE,
NC
27709
|
|
Correspondent Contact |
Brian Gall |
Regulation Number | 868.1400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/05/2014 |
Decision Date | 02/12/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|