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510(k) K894961

MEDISONIC ULTRA-SONIC INHALER by Medisonic U.S.A., Inc. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1989
Date Received
August 7, 1989
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)
  • K901114 — MEDISONIC HUMDIFIER/INHALER (May 22, 1990)
  • K896192 — MEDISONIC PNEU-NEB (January 3, 1990)

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