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LGM

Chamber, Patient Isolation

Product code
LGM
Device name
Chamber, Patient Isolation
Device class
Class 2
21 CFR
21 CFR 880.5450
Medical specialty
General Hospital
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
12 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-01-03.

NumberDecision dateApplicantDevice nameSummary
K2312562024-01-03Carecubes, Inc.Carecube Negative Pressure Isolation ChamberPDF

1 summaries are archived here for direct download.

Official FDA classification page: LGM
Classification and pathway per current FDA publications. Data from openFDA (CC0).