Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
510(k) Number |
K841336 |
Device Name |
NON-INVASIVE BP MODULE 7000 |
Applicant |
MARQUETTE ELECTRONICS, INC. |
P.O. BOX 9100 |
100 MARQUETTE DRIVE |
JUPITER,
FL
33468
|
|
Applicant Contact |
PHILLIP T WEINFURT |
Correspondent |
MARQUETTE ELECTRONICS, INC. |
P.O. BOX 9100 |
100 MARQUETTE DRIVE |
JUPITER,
FL
33468
|
|
Correspondent Contact |
PHILLIP T WEINFURT |
Regulation Number | 870.1130 |
Classification Product Code |
|
Date Received | 04/02/1984 |
Decision Date | 10/26/1984 |
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
|
|
|