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510(k) K991685

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1999
Date Received
May 17, 1999
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.

  • K981772 — HALOLITE AAD SYSTEM (November 3, 1998)
  • K971933 — PORT-NEB (August 1, 1997)
  • K934749 — FREEWAY LITE NEBULIZER COMPRESSOR (July 25, 1994)
  • 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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