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510(k) K852622

AEROSOL ONE by Ashai Co. , Ltd. — Product Code BTI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 1986
Date Received
June 20, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Compressor, Air, Portable
Device Class
Class II
Regulation Number
868.6250
Review Panel
AN
Submission Type

Other clearances by Ashai Co. , Ltd.

  • K870428 — AEROSOL ONE, NEBULIZER PUMP (May 15, 1987)
  • K852620 — SAFE.N.SURE (October 31, 1985)
  • K852627 — MAXI-NEB (September 26, 1985)
  • K852623 — OXY-ONE (September 18, 1985)
  • K852628 — NASAL ONE (September 18, 1985)
  • K852624 — OXY-TWO (September 18, 1985)
  • K852629 — AERO-MASK TWO (September 18, 1985)
  • K852618 — OXY-DIAL (September 18, 1985)
  • K852626 — AERO-MASK ONE (September 18, 1985)
  • K852625 — OXY-TUBE (September 18, 1985)

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