Device Classification Name |
insufflator, hysteroscopic
|
510(k) Number |
K210628 |
Device Name |
X-FLO Fluid Management System |
Applicant |
Thermedx, LLC |
31200 Solon Rd Unit 1 |
Solon,
OH
44139
|
|
Applicant Contact |
Daniel Marijian |
Correspondent |
Thermedx, LLC |
31200 Solon Rd Unit 1 |
Solon,
OH
44139
|
|
Correspondent Contact |
Daniel Marijian |
Regulation Number | 884.1700
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/02/2021 |
Decision Date | 11/04/2021 |
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
|
|
|