FDA Product Code
FDA Product Code LGM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5450
510(k) Clearances — 12 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K231256 | Carecube Negative Pressure Isolation Chamber | Carecubes, Inc. | 2024-01-03 | Traditional | PDF ↗ |
| K163223 | ORCA (tm) - Operational Rescue Containment Apparatus | Isovac Products, LLC | 2017-11-02 | Traditional | PDF ↗ |
| K080117 | PATIENT ISOLATION UNIT, MODEL G019-1000 | Gentex Corporation | 2009-01-30 | Traditional | PDF ↗ |
| K022260 | FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS | Isolation Systems, Inc. | 2002-08-29 | Traditional | PDF ↗ |
| K944133 | MTB 1043 TREATMENT BOOTH | Mark Solutions, Inc. | 1995-09-07 | Traditional | PDF ↗ |
| K912444 | MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM | Radiometer America, Inc. | 1992-02-18 | Traditional | PDF ↗ |
| K896721 | MODEL 7-AT TREATMENT CHAMBER | J. H. Emerson Co. | 1990-01-22 | Traditional | PDF ↗ |
| K884295 | SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE | Saybrex Intl., Inc. | 1988-11-08 | Traditional | PDF ↗ |
| K874306 | INFECTIOUS DISEASE PROTECTION KIT, DISPOSABLE | Busse Hospital Disposables, Inc. | 1988-03-22 | Traditional | PDF ↗ |
| K864116 | ANAGO ISOLATION MASK (#80-950) | Anago, Inc. | 1986-11-25 | Traditional | PDF ↗ |
| K831062 | ISOLATION MASK I.C.S. | American Threshold Industries, Inc. | 1983-04-13 | Traditional | PDF ↗ |
| K790657 | STRETCHER TRANSIT ISOLATER #122 | Vickers America Medical Corp. | 1979-07-03 | Traditional | PDF ↗ |
Product code LGM · Class II · General Hospital. Data: openFDA.