Device Classification Name |
monitor, physiological, patient (without arrhythmia detection or alarms)
|
510(k) Number |
K020494 |
Device Name |
MODIFICATION TO M2376A DEVICELINK SYSTEM |
Applicant |
PHILIPS MEDICAL SYSTEMS, INC. |
3000 MINUTEMAN RD. MS 0491 |
ANDOVER,
MA
01810 -1099
|
|
Applicant Contact |
MIKE HUDON |
Correspondent |
PHILIPS MEDICAL SYSTEMS, INC. |
3000 MINUTEMAN RD. MS 0491 |
ANDOVER,
MA
01810 -1099
|
|
Correspondent Contact |
MIKE HUDON |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 02/13/2002 |
Decision Date | 02/21/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|