Chamber, Patient Isolation

Device Code: 2650

Product Code(s): LGM

Device Classification Information

• Device Type ID: 2650
• Device Name: Chamber, Patient Isolation
• Regulation Description: Patient Care Reverse Isolation Chamber.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); Infection Control Devices Branch (INCB)
• Submission Type: 510(k)
• CFR Regulation Number: 880.5450 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: LGM
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

• Device Type ID: 2650
• Device: Chamber, Patient Isolation
• Product Code: LGM
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Patient Care Reverse Isolation Chamber.
• CFR Regulation Number: 880.5450 [🔎]

Recalls
Manufacturer		Recall Class	Date Posted
1	Life Force Of Tampa, LLC	II	Sep-11-2014

TPLC Last Update: 2019-04-02 20:16:44