FDA 510(k) Application Details - K231256

Device Classification Name	Chamber, Patient Isolation   More FDA Info for this Device
510(K) Number	K231256
Device Name	Chamber, Patient Isolation
Applicant	Carecubes, Inc. 3101 20th Street San Francisco, CA 94110 US Other 510(k) Applications for this Company
Contact	Alexander Laskey Other 510(k) Applications for this Contact
Regulation Number	880.5450   More FDA Info for this Regulation Number
Classification Product Code	LGM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/01/2023
Decision Date	01/03/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review