FDA.reportPublic FDA data

510(k) K223509

Device
Compremium Compartment Compressibility Monitoring System (CPM#1)
Applicant
Compremium AG
510(k) number
K223509
Product code
LXC
Decision
Substantially Equivalent (SESE)
Decision date
2023-04-14
Date received
2022-11-22
Classification name
Monitor, Pressure, Intracompartmental
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Vincent Baumann
Address
Worbstrasse 46 Muri CH 3074 3074

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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