Device Classification Name |
transducer, blood-pressure, extravascular
|
510(k) Number |
K163172 |
Device Name |
HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit |
Applicant |
SMITHS MEDICAL ASD, INC. |
6000 NATHAN LANE N |
Minneapolis,
MN
55442
|
|
Applicant Contact |
Bruce Backlund |
Correspondent |
SMITHS MEDICAL ASD, INC. |
6000 NATHAN LANE N |
Minneapolis,
MN
55442
|
|
Correspondent Contact |
Bruce Backlund |
Regulation Number | 870.2850
|
Classification Product Code |
|
Date Received | 11/14/2016 |
Decision Date | 05/24/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|