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510(k) K944133

MTB 1043 TREATMENT BOOTH by Mark Solutions, Inc. — Product Code LGM

K944133 is an FDA 510(k) premarket notification submitted by Mark Solutions, Inc. for the device "MTB 1043 TREATMENT BOOTH". The FDA issued a decision of Substantially Equivalent on September 7, 1995. 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
September 7, 1995
Date Received
August 24, 1994
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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  • K163223 — ORCA (tm) - Operational Rescue Containment Apparatus (November 2, 2017)
  • K080117 — PATIENT ISOLATION UNIT, MODEL G019-1000 (January 30, 2009)
  • K022260 — FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS (August 29, 2002)
  • 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