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510(k) K912444

MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM by Radiometer America, Inc. — Product Code LGM

K912444 is an FDA 510(k) premarket notification submitted by Radiometer America, Inc. for the device "MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM". The FDA issued a decision of Substantially Equivalent on February 18, 1992. The device falls under product code LGM (Chamber, Patient Isolation), a Class II device regulated under 21 CFR 880.5450. Radiometer America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1992
Date Received
June 3, 1991
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 by Radiometer America, Inc.

  • K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Veri (January 28, 2016)
  • K992859 — ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE (January 10, 2000)
  • K991417 — ABL 735 ANALYZER (November 24, 1999)
  • K982928 — NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM (January 6, 1999)
  • K980130 — ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM (February 9, 1998)
  • K980135 — QUALICHECK5+ MODELS S7730, S7740, S7750, S7760 (January 28, 1998)
  • K974818 — ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM (January 16, 1998)
  • K973367 — ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM (October 6, 1997)
  • K962158 — PICO MODELS 30, 50, 70 (October 29, 1996)
  • K962334 — EML105 ELECTROLYTE METABOLITE ANALYZER (October 24, 1996)

Other clearances for product code LGM

  • K231256 — Carecube Negative Pressure Isolation Chamber (January 3, 2024)
  • 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)
  • 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