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510(k) K883704

MULTIICHALLENGE NEBULIZER SYSTEM by Biotrine Corp. — Product Code BTI

K883704 is an FDA 510(k) premarket notification submitted by Biotrine Corp. for the device "MULTIICHALLENGE NEBULIZER SYSTEM". The FDA issued a decision of Substantially Equivalent on November 28, 1988. The device falls under product code BTI (Compressor, Air, Portable), a Class II device regulated under 21 CFR 868.6250. Biotrine Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1988
Date Received
August 30, 1988
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 Biotrine Corp.

  • K915060 — ASTECH HOME PEAK FLOW METER (September 11, 1992)
  • K863134 — MULTISPIRO SA/100 (December 15, 1986)
  • K844226 — B-1000 (November 20, 1984)
  • K813414 — PEAK FLOW MONITOR (December 31, 1981)
  • K812825 — FLO-COR I (October 26, 1981)

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