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510(k) K031413

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

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

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  • K041516 — DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9 (September 8, 2004)
  • K002831 — VEGA ULTRASONIC NEBULIZER (May 23, 2001)

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  • 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)