Device Classification Name |
transducer, pressure, catheter tip |
|||
---|---|---|---|---|
510(k) Number | K022187 | |||
Device Name | PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304 | |||
Original Applicant |
|
|||
Original Contact | mats granlund | |||
Regulation Number | 870.2870 | |||
Classification Product Code |
|
|||
Subsequent Product Code |
|
|||
Date Received | 07/05/2002 | |||
Decision Date | 09/24/2002 | |||
Decision |
substantially equivalent (SESE) |
|||
Regulation Medical Specialty |
Cardiovascular |
|||
510k Review Panel |
Cardiovascular |
|||
summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |