Device Classification Name |
home uterine activity monitor
|
510(k) Number |
K143114 |
Device Name |
Sense4Baby System Model B+ (MSA) |
Applicant |
AIRSTRIP TECHNOLOGIES, INC. |
565 PLEARL ST. SUITE 209 |
LA JOLLA,
CA
92037
|
|
Applicant Contact |
ROBERT ANDREW MILLER |
Correspondent |
CERTIFIED COMPLIANCE SOLUTIONS, INC. |
11665 AVENA PLACE, SUITE 203 |
SAN DIEGO,
CA
92128
|
|
Correspondent Contact |
CURTIS M EGAN |
Regulation Number | 884.2730
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/30/2014 |
Decision Date | 03/10/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|