Device Classification Name |
detector and alarm, arrhythmia
|
510(k) Number |
K020550 |
Device Name |
PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX |
Applicant |
DATASCOPE CORP. |
800 MACARTHUR BLVD. |
MAHWAH,
NJ
07430 -0619
|
|
Applicant Contact |
RUSSELL OLSEN |
Correspondent |
DATASCOPE CORP. |
800 MACARTHUR BLVD. |
MAHWAH,
NJ
07430 -0619
|
|
Correspondent Contact |
RUSSELL OLSEN |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 02/19/2002 |
Decision Date | 08/28/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|