Device Classification Name |
monitor, physiological, patient(with arrhythmia detection or alarms)
|
510(k) Number |
K091834 |
Device Name |
PASSPORT V MONITOR, MODEL 0998-00-6100 |
Applicant |
DATASCOPE CORP., PATIENT MONITORING DIVISION |
800 MACARTHUR BLVD. |
MAHWAH,
NJ
07430 -0619
|
|
Applicant Contact |
KATHLEEN KRAMER |
Correspondent |
DATASCOPE CORP., PATIENT MONITORING DIVISION |
800 MACARTHUR BLVD. |
MAHWAH,
NJ
07430 -0619
|
|
Correspondent Contact |
KATHLEEN KRAMER |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 06/22/2009 |
Decision Date | 07/15/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|