Device Classification Name |
monitor, ultrasonic, fetal
|
510(k) Number |
K061091 |
Device Name |
BABYBEAT CORDLESS |
Applicant |
THE NEWMAN GROUP, LLC |
935 WEST CHESTNUT ST. |
SUITE 430 |
CHICAGO,
IL
60622
|
|
Applicant Contact |
SPENCER NEWMAN |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 884.2660
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/19/2006 |
Decision Date | 05/04/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|