Device Classification Name |
monitor, pressure, intrauterine
|
510(k) Number |
K901084 |
Device Name |
ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO. |
Applicant |
HEALTHDYNE CARDIOVASCULAR, INC. |
45 PARKER ST., SUITE A |
IRVINE,
CA
92618 -1658
|
|
Applicant Contact |
BILL WELCH |
Correspondent |
HEALTHDYNE CARDIOVASCULAR, INC. |
45 PARKER ST., SUITE A |
IRVINE,
CA
92618 -1658
|
|
Correspondent Contact |
BILL WELCH |
Regulation Number | 884.2700
|
Classification Product Code |
|
Date Received | 03/07/1990 |
Decision Date | 06/01/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|