Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K223509
Device Classification Name
Monitor, Pressure, Intracompartmental
More FDA Info for this Device
510(K) Number
K223509
Device Name
Monitor, Pressure, Intracompartmental
Applicant
Compremium AG
Worbstrasse 46
Muri b. Bern 3074 CH
Other 510(k) Applications for this Company
Contact
Vincent Baumann
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LXC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/22/2022
Decision Date
04/14/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact