Device Classification Name |
System, Gastrointestinal Motility (Electrical)
|
510(k) Number |
K190208 |
Device Name |
Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe |
Applicant |
Diversatek Healthcare |
9150 Commerce Center Circle |
Suite 500 |
Highlands Ranch,
CO
80129
|
|
Applicant Contact |
Laura L. Boll |
Correspondent |
Diversatek Healthcare |
9150 Commerce Center Circle |
Suite 500 |
Highlands Ranch,
CO
80129
|
|
Correspondent Contact |
Laura L. Boll |
Regulation Number | 876.1725
|
Classification Product Code |
|
Date Received | 02/04/2019 |
Decision Date | 10/03/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|