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510(k) K933535

VENTSTREAM DRUG NEBULIZER by Medic-Aid , Ltd. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1994
Date Received
July 21, 1993
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

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  • K940887 — SYSTEM 22 ADULT MASK (April 19, 1994)
  • K924123 — SIDESTREAM DISPOSABLE (November 16, 1992)
  • K914152 — SIDESTREAM DRUG NEBULIZER (May 5, 1992)

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