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510(k) K022260

FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS by Isolation Systems, Inc. — Product Code LGM

K022260 is an FDA 510(k) premarket notification submitted by Isolation Systems, Inc. for the device "FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS". The FDA issued a decision of Substantially Equivalent on August 29, 2002. The device falls under product code LGM (Chamber, Patient Isolation), a Class II device regulated under 21 CFR 880.5450.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2002
Date Received
June 28, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chamber, Patient Isolation
Device Class
Class II
Regulation Number
880.5450
Review Panel
HO
Submission Type

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  • K080117 — PATIENT ISOLATION UNIT, MODEL G019-1000 (January 30, 2009)
  • K944133 — MTB 1043 TREATMENT BOOTH (September 7, 1995)
  • K912444 — MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM (February 18, 1992)
  • K896721 — MODEL 7-AT TREATMENT CHAMBER (January 22, 1990)
  • K884295 — SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE (November 8, 1988)
  • K874306 — INFECTIOUS DISEASE PROTECTION KIT, DISPOSABLE (March 22, 1988)
  • K864116 — ANAGO ISOLATION MASK (#80-950) (November 25, 1986)
  • K831062 — ISOLATION MASK I.C.S. (April 13, 1983)

FDA data resources