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510(k) K092029

VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310 by Draeger Medical AG & Co. KG — Product Code BYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2010
Date Received
July 6, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Attachment, Breathing, Positive End Expiratory Pressure
Device Class
Class II
Regulation Number
868.5965
Review Panel
AN
Submission Type

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  • K083050 — EVITE XL (December 29, 2008)
  • K081447 — FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO (October 8, 2008)
  • K081743 — CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS (September 22, 2008)
  • K072884 — FABIUS MRI (July 30, 2008)
  • K072885 — CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110 (April 7, 2008)
  • K072002 — FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55 (January 31, 2008)

Other clearances for product code BYE

  • K160112 — Besmed PEEP Valve (April 29, 2016)
  • K133957 — DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE (April 14, 2014)
  • K133210 — B&B BUBBLER (March 28, 2014)
  • K122610 — PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES (August 5, 2013)
  • K112546 — O_TWO CPAP SYSTEM (December 27, 2011)
  • K110713 — WATERPAP VALVE (September 12, 2011)
  • K103833 — NEOPIP PATIENT CIRCUIT WITH PEEP (April 20, 2011)
  • K090710 — MERCURY CPAP (August 20, 2009)
  • K090317 — BABI*PLUS BUBBLE PAP VALVE (May 20, 2009)
  • K081266 — MERCURY MEDICAL PEEP VALVE (March 5, 2009)