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510(k) K102625

VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-03 by Vega Technologies, Inc. — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2011
Date Received
September 13, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Non-Continuous (Respirator)
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

Other clearances by Vega Technologies, Inc.

  • 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)
  • K031413 — VIGORMIST COMPRESSOR NEBULIZER (October 7, 2003)
  • K002831 — VEGA ULTRASONIC NEBULIZER (May 23, 2001)

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