Device Classification Name |
monitor, physiological, patient (without arrhythmia detection or alarms)
|
510(k) Number |
K051897 |
Device Name |
TRIO MONITOR |
Applicant |
DATASCOPE CORP. |
800 MACARTHUR BLVD. |
MAHWAH,
NJ
07430 -0619
|
|
Applicant Contact |
SUSAN E MANDY |
Correspondent |
DATASCOPE CORP. |
800 MACARTHUR BLVD. |
MAHWAH,
NJ
07430 -0619
|
|
Correspondent Contact |
SUSAN E MANDY |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 07/13/2005 |
Decision Date | 08/12/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|