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510(k) K981772

HALOLITE AAD SYSTEM by Medic-Aid , Ltd. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1998
Date Received
May 19, 1998
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 Medic-Aid , Ltd.

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  • K940888 — SYSTEM 22 PAEDIATRIC MASK (April 19, 1994)
  • K940887 — SYSTEM 22 ADULT MASK (April 19, 1994)
  • K933535 — VENTSTREAM DRUG NEBULIZER (January 24, 1994)
  • K924123 — SIDESTREAM DISPOSABLE (November 16, 1992)
  • K914152 — SIDESTREAM DRUG NEBULIZER (May 5, 1992)

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