FDA.reportPublic FDA data

510(k) K231256

Device
Carecube Negative Pressure Isolation Chamber
Applicant
Carecubes, Inc.
510(k) number
K231256
Product code
LGM
Decision
Substantially Equivalent (SESE)
Decision date
2024-01-03
Date received
2023-05-01
Regulation
880.5450
Classification name
Chamber, Patient Isolation
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Alexander Laskey
Address
3101 20th St. San Francisco CA US 94110 94110

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LGM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K163223ORCA (tm) - Operational Rescue Containment ApparatusIsovac Products, LLC2017-11-02
K080117PATIENT ISOLATION UNIT, MODEL G019-1000Gentex Corporation2009-01-30
K022260FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMSIsolation Systems, Inc.2002-08-29
K944133MTB 1043 TREATMENT BOOTHMark Solutions, Inc.1995-09-07
K912444MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEMRadiometer America, Inc.1992-02-18
K896721MODEL 7-AT TREATMENT CHAMBERJ. H. Emerson Co.1990-01-22
K884295SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVESaybrex Intl., Inc.1988-11-08
K874306INFECTIOUS DISEASE PROTECTION KIT, DISPOSABLEBusse Hospital Disposables, Inc.1988-03-22
K864116ANAGO ISOLATION MASK (#80-950)Anago, Inc.1986-11-25
K831062ISOLATION MASK I.C.S.American Threshold Industries, Inc.1983-04-13
K790657STRETCHER TRANSIT ISOLATER #122Vickers America Medical Corp.1979-07-03