Device Classification Name |
transducer, blood-pressure, extravascular
|
510(k) Number |
K831506 |
Device Name |
DISP. TRANSDUCER W/MONITORING KIT TRANS |
Applicant |
SORENSEN RESEARCH |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
SORENSEN RESEARCH |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 870.2850
|
Classification Product Code |
|
Date Received | 05/11/1983 |
Decision Date | 08/12/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|