FDA Product Code LGM: Chamber, Patient Isolation
Leading manufacturers include Carecubes, Inc..
12
Total
12
Cleared
170d
Avg days
1979
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Chamber, Patient Isolation Devices (Product Code LGM)
12 devices
About Product Code LGM - Regulatory Context
510(k) Submission Activity
12 total 510(k) submissions under product code LGM since 1979, with 12 receiving FDA clearance (average review time: 170 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
LGM devices are reviewed by the General Hospital panel. Browse all General Hospital devices →