FDA 510(k) Applications for Medical Device Product Code "LGM"
(Chamber, Patient Isolation)

FDA 510(k) Number Applicant Device Name Decision Date
K231256 Carecubes, Inc. Carecube Negative Pressure Isolation Chamber 01/03/2024
K080117 GENTEX CORPORATION PATIENT ISOLATION UNIT, MODEL G019-1000 01/30/2009
K022260 ISOLATION SYSTEMS, INC. FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS 08/29/2002
K163223 ISOVAC PRODUCTS, LLC ORCA (tm) - Operational Rescue Containment Apparatus 11/02/2017


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