LGM — Chamber, Patient Isolation Class II
FDA Device Classification
Classification Details
- Product Code
- LGM
- Device Class
- Class II
- Regulation Number
- 880.5450
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
| K231256 | carecubes | Carecube Negative Pressure Isolation Chamber | January 3, 2024 |
| K163223 | isovac products | ORCA (tm) - Operational Rescue Containment Apparatus | November 2, 2017 |
| K080117 | gentex corporation | PATIENT ISOLATION UNIT, MODEL G019-1000 | January 30, 2009 |
| K022260 | isolation systems | FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS | August 29, 2002 |
| K944133 | mark solutions | MTB 1043 TREATMENT BOOTH | September 7, 1995 |
| K912444 | radiometer america | MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM | February 18, 1992 |
| K896721 | j. h. emerson | MODEL 7-AT TREATMENT CHAMBER | January 22, 1990 |
| K884295 | saybrex intl | SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE | November 8, 1988 |
| K874306 | busse hospital disposables | INFECTIOUS DISEASE PROTECTION KIT, DISPOSABLE | March 22, 1988 |
| K864116 | anago | ANAGO ISOLATION MASK (#80-950) | November 25, 1986 |
| K831062 | american threshold industries | ISOLATION MASK I.C.S. | April 13, 1983 |
| K790657 | vickers america medical | STRETCHER TRANSIT ISOLATER #122 | July 3, 1979 |