510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LGMClass II

Chamber, Patient Isolation

21 CFR 880.5450 / General Hospital
FDA source (opens on fda.gov)

LGM is the FDA product code for Chamber, Patient Isolation, a class II device type, regulated under 21 CFR 880.5450. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
LGM
Device name
Chamber, Patient Isolation
Regulation
21 CFR 880.5450
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
12
Ingested recalls
1

Clearances, product code LGM

By decision year
12 clearances under product code LGM with a decision year between 1979 and 2024, 1988 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LGM by decision year
YearClearances
19791
19831
19861
19882
19901
19921
19951
20021
20091
20171
20241

Applicants with the most clearances

Product code LGM
Applicants holding the most 510(k) clearances under product code LGM
ApplicantClearances
American Threshold Industries, Inc.1
Anago, Inc.1
Busse Hospital Disposables1
Carecubes, Inc.1
Gentex Corporation1
Isolation Systems, Inc.1
Isovac Products LLC1
J. H. Emerson Co.1
Mark Solutions, Inc.1
Radiometer America, Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code