Device Classification Name |
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
|
510(k) Number |
K033680 |
Device Name |
M2376A PHILIPS DEVICE LINK SYSTEM |
Applicant |
PHILIPS MEDICAL SYSTEMS |
HEWLETT PACKARD STR. 2 |
BOBLINGEN,
DE
D71034
|
|
Applicant Contact |
HERBERT VAN DYK |
Correspondent |
PHILIPS MEDICAL SYSTEMS |
HEWLETT PACKARD STR. 2 |
BOBLINGEN,
DE
D71034
|
|
Correspondent Contact |
HERBERT VAN DYK |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 11/24/2003 |
Decision Date | 12/11/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|