Device Classification Name |
perineometer
|
510(k) Number |
K143580 |
Device Name |
PeriCoach |
Applicant |
ANALYTICA LTD |
320 ADELAIDE STREET |
brisbane,
AU
4000
|
|
Applicant Contact |
geoff daly |
Correspondent |
Brandwood Biomedical |
408, 406 Pacific Highway |
st leonards,
AU
2065
|
|
Correspondent Contact |
tracey bullivant |
Regulation Number | 884.1425
|
Classification Product Code |
|
Date Received | 12/18/2014 |
Decision Date | 03/18/2015 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Gastroenterology/Urology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|