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510(k) K901114

MEDISONIC HUMDIFIER/INHALER by Medisonic U.S.A., Inc. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1990
Date Received
March 7, 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 Medisonic U.S.A., Inc.

  • K924577 — MEDIVAC (March 23, 1993)
  • K923660 — MEDISONIC OXYGEN FLOW CONTROLLER (January 27, 1993)
  • K896192 — MEDISONIC PNEU-NEB (January 3, 1990)
  • K894961 — MEDISONIC ULTRA-SONIC INHALER (November 24, 1989)

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