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510(k) K231256

Carecube Negative Pressure Isolation Chamber by Carecubes, Inc. — Product Code LGM

K231256 is an FDA 510(k) premarket notification submitted by Carecubes, Inc. for the device "Carecube Negative Pressure Isolation Chamber". The FDA issued a decision of Substantially Equivalent on January 3, 2024. 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
January 3, 2024
Date Received
May 1, 2023
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

Other clearances for product code LGM

  • 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)
  • 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