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510(k) K760891

INSPIRON I.M.V. SET UP by Inspiron Corp. — Product Code CBO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1976
Date Received
October 26, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Attachment, Intermittent Mandatory Ventilation (Imv)
Device Class
Class II
Regulation Number
868.5955
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)
  • K843932 — VAPOR-PHASE HUMIDIFIER SYS-ADVANCED (October 18, 1984)
  • 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)

Other clearances for product code CBO

  • K811991 — SIMVAC (August 12, 1981)
  • K811908 — IMV MANIFOLDS (July 16, 1981)
  • K791912 — IMV FOR MONITORING #M-510 (October 9, 1979)
  • K791913 — IMV MANIFOLD #M-506 (October 9, 1979)
  • K791906 — IMV W/BAG #M-507 (October 9, 1979)
  • K791909 — IMV BUSHING #M-513 (October 9, 1979)
  • K791905 — IMV W/BAG & TUBING #M-508 (October 9, 1979)
  • K791904 — IMV W/BAG & HOSES #M-509 (October 9, 1979)
  • K791911 — FALL-SAFE IMV #M-511 (October 9, 1979)
  • K781706 — RESPIRATOR/GILL 1/SIMV (January 22, 1979)