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510(k) K852622

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

K852622 is an FDA 510(k) premarket notification submitted by Ashai Co. , Ltd. for the device "AEROSOL ONE". The FDA issued a decision of Substantially Equivalent on April 24, 1986. The device falls under product code BTI (Compressor, Air, Portable), a Class II device regulated under 21 CFR 868.6250. Ashai Co. , Ltd. has at least 10 other 510(k) clearances on record.

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)
  • K852624 — OXY-TWO (September 18, 1985)
  • K852628 — NASAL ONE (September 18, 1985)
  • K852629 — AERO-MASK TWO (September 18, 1985)
  • K852626 — AERO-MASK ONE (September 18, 1985)
  • K852625 — OXY-TUBE (September 18, 1985)
  • K852623 — OXY-ONE (September 18, 1985)
  • K852618 — OXY-DIAL (September 18, 1985)

Other clearances for product code BTI

  • K131881 — OMBRA TABLE TOP COMPRESSOR (October 24, 2013)
  • K113338 — MEDICAL AIR COMPRESSOR (August 10, 2012)
  • K091871 — DK50 DS (October 23, 2009)
  • K072634 — EMG TRITON -COMP,MODEL NCA01-XXX SERIES (November 19, 2008)
  • K060781 — MEDICAL COMPRESSOR, MODELS DK50 D AND DM (October 3, 2006)
  • K051691 — MINIMATE COMPRESSOR (December 9, 2005)
  • K041781 — VENTILAIR II MEDICAL AIR COMPRESSOR (March 14, 2005)
  • K041406 — NEWPORT C250 AIR COMPRESSOR MODEL C250 (December 15, 2004)
  • K041974 — MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER (August 24, 2004)
  • K040220 — MEDICAL AIR COMPRESSOR (June 9, 2004)

FDA data resources