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510(k) K041974

MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER by Med2000 S.R.L. — Product Code BTI

K041974 is an FDA 510(k) premarket notification submitted by Med2000 S.R.L. for the device "MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER". The FDA issued a decision of Substantially Equivalent on August 24, 2004. The device falls under product code BTI (Compressor, Air, Portable), a Class II device regulated under 21 CFR 868.6250. Med2000 S.R.L. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2004
Date Received
July 22, 2004
Clearance Type
Special
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 Med2000 S.R.L.

  • K041327 — MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES (July 20, 2004)
  • K031908 — MED2000 SPA NEBULIZER COMPRESSORS, MODELS P1 AND P2, WITH NEBULIZER, AND MED2000 (January 14, 2004)

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)
  • K040220 — MEDICAL AIR COMPRESSOR (June 9, 2004)
  • K031686 — AEROMIST LT, MODEL HCS15004 (January 21, 2004)

FDA data resources