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