Device Classification Name |
Monitor, Pressure, Intracompartmental
|
510(k) Number |
K223509 |
Device Name |
Compremium Compartment Compressibility Monitoring System (CPM#1) |
Applicant |
Compremium AG |
Worbstrasse 46 |
Muri b. Bern,
CH
3074
|
|
Applicant Contact |
Vincent Baumann |
Correspondent |
Medidee Services LLC |
300 Welsh Road, Building 1, Suite 100 |
Horsham,
PA
19044
|
|
Correspondent Contact |
Philippe Etter |
Classification Product Code |
|
Date Received | 11/22/2022 |
Decision Date | 04/14/2023 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT05483946
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|