Panels › General Hospital › Product code LGM · Class 2
Chamber, Patient Isolation
Regulation 880.5450
1510(k)s in 12 months (13 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in LGM
| Company | 510(k)s | Recalls |
|---|---|---|
| Carecubes, Inc. | 2 | 0 |
| American Threshold Industries, Inc. | 1 | 0 |
| Anago, Inc. | 1 | 0 |
| Busse Hospital Disposables, Inc. | 1 | 0 |
| Gentex Corporation | 1 | 0 |
| Isolation Systems, Inc. | 1 | 0 |
| Isovac Products, LLC | 1 | 0 |
| J. H. Emerson Co. | 1 | 0 |
| Life Force of Tampa, LLC | 0 | 1 |
| Mark Solutions, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 16, 2026 | K260180 | Carecube Negative Pressure Isolation Chamber (1BY) Carecubes, Inc. | LGM |
| Jan 3, 2024 | K231256 | Carecube Negative Pressure Isolation Chamber Carecubes, Inc. | LGM |
| Nov 2, 2017 | K163223 | ORCA (tm) - Operational Rescue Containment Apparatus Isovac Products, LLC | LGM |
| Jan 30, 2009 | K080117 | PATIENT ISOLATION UNIT, MODEL G019-1000 Gentex Corporation | LGM |
| Aug 29, 2002 | K022260 | FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS Isolation Systems, Inc. | LGM |
| Sep 7, 1995 | K944133 | MTB 1043 TREATMENT BOOTH Mark Solutions, Inc. | LGM |
| Feb 18, 1992 | K912444 | MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM Radiometer America, Inc. | LGM |
| Jan 22, 1990 | K896721 | MODEL 7-AT TREATMENT CHAMBER J. H. Emerson Co. | LGM |
| Nov 8, 1988 | K884295 | SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE Saybrex Intl., Inc. | LGM |
| Mar 22, 1988 | K874306 | INFECTIOUS DISEASE PROTECTION KIT, DISPOSABLE Busse Hospital Disposables, Inc. | LGM |
| Nov 25, 1986 | K864116 | ANAGO ISOLATION MASK (#80-950) Anago, Inc. | LGM |
| Apr 13, 1983 | K831062 | ISOLATION MASK I.C.S. American Threshold Industries, Inc. | LGM |
| Jul 3, 1979 | K790657 | STRETCHER TRANSIT ISOLATER #122 Vickers America Medical Corp. | LGM |
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