Device Classification Name |
Transducer, Blood-Pressure, Extravascular
|
510(k) Number |
K803096 |
Device Name |
NARCO TELECARE TRANSDUCER DOME #700-4000 |
Applicant |
NARCO SCIENTIFIC |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
NARCO SCIENTIFIC |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 870.2850 |
Classification Product Code |
|
Date Received | 12/08/1980 |
Decision Date | 01/13/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|