Product code LGM— General Hospital
ANAGO ISOLATION MASK (#80-950)
- Classification name
- Chamber, Patient Isolation
- Device class
- Class 2
- Regulation
- 21 CFR 880.5450
- Advisory panel
- General Hospital
- Total cleared
- 12
- First cleared
- Most recent
Market context for product code LGM
FDA has cleared devices under product code LGM between 1979 and 2024, filed by 12 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2024
- 2017
- 2009
- 2002
- 1995
- 1992
- 1990
- 1988
- 1986
- 1983
- 1979
Top applicants under product code LGM
Recent clearances under product code LGM
- K231256 — Carecube Negative Pressure Isolation Chamber
- K163223 — ORCA (tm) - Operational Rescue Containment Apparatus
- K080117 — PATIENT ISOLATION UNIT, MODEL G019-1000
- K022260 — FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS
- K944133 — MTB 1043 TREATMENT BOOTH
- K912444 — MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM
- K896721 — MODEL 7-AT TREATMENT CHAMBER
- K884295 — SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE
- K874306 — INFECTIOUS DISEASE PROTECTION KIT, DISPOSABLE
- K864116 — ANAGO ISOLATION MASK (#80-950)
- K831062 — ISOLATION MASK I.C.S.
- K790657 — STRETCHER TRANSIT ISOLATER #122
Data sourced from openFDA. This site is unofficial and independent of the FDA.