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510(k) K031413

VIGORMIST COMPRESSOR NEBULIZER by Vega Technologies, Inc. — Product Code BTI

K031413 is an FDA 510(k) premarket notification submitted by Vega Technologies, Inc. for the device "VIGORMIST COMPRESSOR NEBULIZER". The FDA issued a decision of Substantially Equivalent on October 7, 2003. The device falls under product code BTI (Compressor, Air, Portable), a Class II device regulated under 21 CFR 868.6250. Vega Technologies, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2003
Date Received
May 5, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Vega Technologies, Inc.

  • K102625 — VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-03 (June 10, 2011)
  • K102934 — INFRARED EAR THERMOMETER, MODEL IR-04MT (January 14, 2011)
  • K102626 — VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01 (November 12, 2010)
  • K041516 — DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9 (September 8, 2004)
  • K002831 — VEGA ULTRASONIC NEBULIZER (May 23, 2001)

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