Device Classification Name |
Oximeter
|
510(k) Number |
K091572 |
Device Name |
DISPOSABLE SPO2 SENSOR M1134A |
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 | 870.2700
|
Classification Product Code |
|
Date Received | 06/02/2009 |
Decision Date | 09/22/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|