LGM — Chamber, Patient Isolation Class II
FDA product code LGM covers "Chamber, Patient Isolation", a Class II medical device regulated under 21 CFR 880.5450. Submissions are reviewed by the General Hospital panel. At least 12 recent 510(k) clearances have been granted under this product code.
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 |