LGM — Chamber, Patient Isolation Class II

FDA Device Classification

Classification Details

Product Code
LGM
Device Class
Class II
Regulation Number
880.5450
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K231256carecubesCarecube Negative Pressure Isolation ChamberJanuary 3, 2024
K163223isovac productsORCA (tm) - Operational Rescue Containment ApparatusNovember 2, 2017
K080117gentex corporationPATIENT ISOLATION UNIT, MODEL G019-1000January 30, 2009
K022260isolation systemsFAILSAFE - PORTABLE INFECTION CONTROL SYSTEMSAugust 29, 2002
K944133mark solutionsMTB 1043 TREATMENT BOOTHSeptember 7, 1995
K912444radiometer americaMICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEMFebruary 18, 1992
K896721j. h. emersonMODEL 7-AT TREATMENT CHAMBERJanuary 22, 1990
K884295saybrex intlSURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVENovember 8, 1988
K874306busse hospital disposablesINFECTIOUS DISEASE PROTECTION KIT, DISPOSABLEMarch 22, 1988
K864116anagoANAGO ISOLATION MASK (#80-950)November 25, 1986
K831062american threshold industriesISOLATION MASK I.C.S.April 13, 1983
K790657vickers america medicalSTRETCHER TRANSIT ISOLATER #122July 3, 1979