Device Classification Name |
transducer, blood-pressure, extravascular
|
510(k) Number |
K221782 |
Device Name |
Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes |
Applicant |
Merit Medical Pte. Ltd. |
198 Yishun Avenue 7 |
Singapore,
SG
768926
|
|
Applicant Contact |
Pauline Liow |
Correspondent |
Merit Medical Pte. Ltd. |
198 Yishun Avenue 7 |
Singapore,
SG
768926
|
|
Correspondent Contact |
Pauline Liow |
Regulation Number | 870.2850
|
Classification Product Code |
|
Date Received | 06/21/2022 |
Decision Date | 03/17/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|