Device Classification Name |
monitor, carbon-dioxide, cutaneous
|
510(k) Number |
K093154 |
Device Name |
TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM |
Applicant |
RADIOMETER MEDICAL APS |
AKANDEVEJ 21 |
BRONSHOJ,
DK
DK-2700
|
|
Applicant Contact |
JANA HELLMAN |
Correspondent |
RADIOMETER MEDICAL APS |
AKANDEVEJ 21 |
BRONSHOJ,
DK
DK-2700
|
|
Correspondent Contact |
JANA HELLMAN |
Regulation Number | 868.2480
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/06/2009 |
Decision Date | 02/05/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|