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510(k) K932557

HYPERINFLATION SYSTEM by Life Shield Healthcare Products, Inc. — Product Code BZR

K932557 is an FDA 510(k) premarket notification submitted by Life Shield Healthcare Products, Inc. for the device "HYPERINFLATION SYSTEM". The FDA issued a decision of Substantially Equivalent on July 22, 1993. The device falls under product code BZR (Mixer, Breathing Gases, Anesthesia Inhalation), a Class II device regulated under 21 CFR 868.5330. Life Shield Healthcare Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1993
Date Received
May 27, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mixer, Breathing Gases, Anesthesia Inhalation
Device Class
Class II
Regulation Number
868.5330
Review Panel
AN
Submission Type

Other clearances by Life Shield Healthcare Products, Inc.

  • K932562 — GAS SAMPLING LINES AND CONNECTORS (July 23, 1993)
  • K932560 — VOLUME VENTILATORS (July 22, 1993)
  • K932558 — ADULT ANESTHESIA BREATHING CIRCUIT (July 22, 1993)
  • K932561 — GUEDEL AIRWAYS (July 22, 1993)
  • K932559 — MAPLESON D CIRCUITS (July 16, 1993)
  • K932563 — VENTILATOR HOSES (July 16, 1993)
  • K932193 — PEDIATRIC TEMPERATURE MONITORING CIRCUITS (July 2, 1993)
  • K932194 — PEDIATRIC GASSAMPLING CIRCUITS (July 2, 1993)
  • K932191 — BREATHING BAGS (July 2, 1993)
  • K932195 — ADULT GAS SAMPLING CIRCUITS (July 2, 1993)

Other clearances for product code BZR

  • K243917 — F&P Optiflow Air/Oxygen Flow Source (July 14, 2025)
  • K241465 — Midas Flowmeter; eAVS (September 19, 2024)
  • K231895 — Maxtec MaxBlend2+p (December 4, 2023)
  • K230987 — FlowStar Analog Mixer Flowmeter (September 14, 2023)
  • K222794 — FlowStar Touch Digital Mixer Flowmeter (July 28, 2023)
  • K221494 — Quality Mix Blender, Oxymixer (January 23, 2023)
  • K202480 — Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 (April 22, 2021)
  • K173205 — Equinox Advantage (August 29, 2018)
  • K161718 — MaxBlend 2, MaxBlend Lite (October 27, 2016)
  • K142291 — GMX Series Medical Air/Oxygen Blender (May 19, 2015)

FDA data resources