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510(k) K870428

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

K870428 is an FDA 510(k) premarket notification submitted by Ashai Co. , Ltd. for the device "AEROSOL ONE, NEBULIZER PUMP". The FDA issued a decision of Substantially Equivalent on May 15, 1987. 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
May 15, 1987
Date Received
February 3, 1987
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.

  • K852622 — AEROSOL ONE (April 24, 1986)
  • K852620 — SAFE.N.SURE (October 31, 1985)
  • K852627 — MAXI-NEB (September 26, 1985)
  • K852625 — OXY-TUBE (September 18, 1985)
  • K852628 — NASAL ONE (September 18, 1985)
  • K852629 — AERO-MASK TWO (September 18, 1985)
  • K852626 — AERO-MASK ONE (September 18, 1985)
  • K852618 — OXY-DIAL (September 18, 1985)
  • K852623 — OXY-ONE (September 18, 1985)
  • K852624 — OXY-TWO (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