Device Classification Name |
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
|
510(k) Number |
K002725 |
Device Name |
MICROPAQ, MODELS 402 AND 404 |
Applicant |
PROTOCOL SYSTEMS, INC. |
8500 S.W. CREEKSIDE PLACE |
BEAVERTON,
OR
97008 -7101
|
|
Applicant Contact |
DON M ABBEY |
Correspondent |
PROTOCOL SYSTEMS, INC. |
8500 S.W. CREEKSIDE PLACE |
BEAVERTON,
OR
97008 -7101
|
|
Correspondent Contact |
DON M ABBEY |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 08/31/2000 |
Decision Date | 11/21/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|