Device Classification Name |
Uterine Electromyographic Monitor
|
510(k) Number |
K153262 |
Device Name |
PUREtrace™ |
Applicant |
NEMO HEALTHCARE BV |
De Run 4630 5504 DB |
Veldhoven,
NL
|
|
Applicant Contact |
Aron Wierts |
Correspondent |
NEMO HEALTHCARE BV |
De Run 4630 5504 DB |
Veldhoven,
NL
|
|
Correspondent Contact |
Aron Wierts |
Regulation Number | 884.2720
|
Classification Product Code |
|
Date Received | 11/10/2015 |
Decision Date | 02/07/2017 |
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
|
|
|