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510(k) K901315

AEROMIST II NEBULIZER by Inhalation Plastics — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 1990
Date Received
March 21, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

Other clearances by Inhalation Plastics

  • K945565 — SPIRO-FLEX (January 13, 1995)
  • K914686 — THERMO-FLOW SET (April 15, 1992)
  • K900990 — FILT-R-ALL BACTERIAL/VIRAL FILTER (April 19, 1990)
  • K900594 — ANESTHESIA BREATHING CIRCUIT (March 15, 1990)
  • K896832 — FILT-R-ALL BACTERIAL FILTER (January 22, 1990)
  • K874659 — STERILIZATION OF DEVICES BY RADIATION (February 2, 1988)

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