| 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 Dr. |
|
Jupiter,
FL
33468
|
|
| Applicant Contact |
PHILLIP T WEINFURT |
| Correspondent |
| Marquette Electronics, Inc. |
| P.O. Box 9100 |
| 100 Marquette Dr. |
|
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
|
|
|