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

Chamber, Patient Transport Isolation

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

LGN is the FDA product code for Chamber, Patient Transport Isolation, a class II device type, regulated under 21 CFR 880.5450. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LGN
Device name
Chamber, Patient Transport 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
2
Ingested recalls
0

Clearances, product code LGN

By decision year
2 clearances under product code LGN with a decision year between 1979 and 2006, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LGN by decision year
YearClearances
19791
20061

Applicants with the most clearances

Product code LGN
Applicants holding the most 510(k) clearances under product code LGN
ApplicantClearances
Isovac Products LLC1
Vickers America Medical Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code