Device Classification Name |
System, Monitoring, Perinatal
|
510(k) Number |
K090269 |
Device Name |
AIRSTRIP OB |
Applicant |
AIRSTRIP TECHNOLOGIES, LP |
3303 OAKWELL CT., SUITE 200 |
SAN ANTONIO,
TX
78218
|
|
Applicant Contact |
WM CAMERON POWELL |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 884.2740
|
Classification Product Code |
|
Date Received | 02/03/2009 |
Decision Date | 02/13/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|