Device Classification Name |
monitor, carbon-dioxide, cutaneous
|
510(k) Number |
K110474 |
Device Name |
PHILIPS INTELLIVUE TCG10 |
Applicant |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
HEWLETT-PACKARD STR.2 |
BOEBLINGEN,
DE
D 71034
|
|
Applicant Contact |
JENS-PETER SEHER |
Correspondent |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
HEWLETT-PACKARD STR.2 |
BOEBLINGEN,
DE
D 71034
|
|
Correspondent Contact |
JENS-PETER SEHER |
Regulation Number | 868.2480
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/18/2011 |
Decision Date | 09/30/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|