Device Classification Name |
transducer, blood-pressure, extravascular
|
510(k) Number |
K780797 |
Device Name |
TRANSDUCER, PRESSURE, OPTION, H-P, P23ID |
Applicant |
GOULD, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Applicant Contact |
none none |
Correspondent |
GOULD, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent Contact |
none none |
Regulation Number | 870.2850
|
Classification Product Code |
|
Date Received | 05/15/1978 |
Decision Date | 06/13/1978 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|