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510(k) K843932

VAPOR-PHASE HUMIDIFIER SYS-ADVANCED by Inspiron Corp. — Product Code BTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1984
Date Received
October 5, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5450
Review Panel
AN
Submission Type

Other clearances by Inspiron Corp.

  • K860838 — INSPIRON DOUBLE SWIVEL TRACH ADAPTER (April 9, 1986)
  • K850346 — OXYGEN CONCENTRATOR (February 4, 1985)
  • K840935 — MANUAL RESUSCITATION SYSTEM (April 5, 1984)
  • K841158 — NEBULO 28 NEBULIZER KIT (March 30, 1984)
  • K840418 — INSPIRATORY/EXPIRATORY MUSCLE EXERCIS (February 17, 1984)
  • K834290 — INSPIRON LIQUID OXYGEN SYSTEM (February 4, 1984)
  • K772071 — MANIFOLD & NEBU. FOR SINGLE LINE MACH. (November 15, 1977)
  • K772072 — MANIFOLD & NEBU. FOR DOUB. LINE MACH. (November 15, 1977)
  • K772068 — MANIFOLD & NEBULIZER, UNIVERSAL (November 15, 1977)
  • K772069 — VOL. VENTILATOR SETUP W/OUT NEBULIZER (November 15, 1977)

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