Device Classification Name |
Oximeter
|
510(k) Number |
K032979 |
Device Name |
PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T |
Applicant |
PHILIPS MEDICAL SYSTEMS, INC. |
HEWLETT PACKARD STR. 2 |
BOBLINGEN,
DE
D71034
|
|
Applicant Contact |
EGON PFEIL |
Correspondent |
PHILIPS MEDICAL SYSTEMS, INC. |
HEWLETT PACKARD STR. 2 |
BOBLINGEN,
DE
D71034
|
|
Correspondent Contact |
EGON PFEIL |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 09/24/2003 |
Decision Date | 02/20/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|