Device Classification Name |
Oximeter
|
510(k) Number |
K081937 |
Device Name |
PICOSAT II AND M3002A MULTIMEASUREMENT AND M1020B PLUG-IN MODULES SPO2 PULSE OXIMETRY MODULE |
Applicant |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH |
HEWLETT-PACKARD STR.2 |
BOEBLINGEN,
DE
D-71034
|
|
Applicant Contact |
JENS-PETER SEHER |
Correspondent |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH |
HEWLETT-PACKARD STR.2 |
BOEBLINGEN,
DE
D-71034
|
|
Correspondent Contact |
JENS-PETER SEHER |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 07/07/2008 |
Decision Date | 08/29/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|