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510(k) K090710

MERCURY CPAP by Mercury Medical — Product Code BYE

K090710 is an FDA 510(k) premarket notification submitted by Mercury Medical for the device "MERCURY CPAP". The FDA issued a decision of Substantially Equivalent on August 20, 2009. The device falls under product code BYE (Attachment, Breathing, Positive End Expiratory Pressure), a Class II device regulated under 21 CFR 868.5965. Mercury Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2009
Date Received
March 18, 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

Other clearances by Mercury Medical

  • K142096 — T-PIECE RESUSCITATOR (October 17, 2014)
  • K093913 — MERCURY MEDICAL T-PIECE RESUSCITATOR (April 6, 2010)
  • K083056 — NEO-STAT CO2 <KG (February 23, 2009)
  • K032593 — MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER (February 3, 2004)
  • K031814 — STATCO2METER, MODEL 10-55372 (August 14, 2003)
  • K031411 — MINI STATCO2 CO2 DETECTOR, MODEL 10-55371 (July 30, 2003)
  • K021576 — MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370 (November 4, 2002)
  • K001714 — MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149 (November 3, 2000)
  • K000073 — MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA (March 1, 2000)
  • K970756 — MERCURY MEDICAL REUSABLE CPR BAG (October 31, 1997)

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)
  • K092029 — VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310 (August 6, 2010)
  • K090317 — BABI*PLUS BUBBLE PAP VALVE (May 20, 2009)
  • K081266 — MERCURY MEDICAL PEEP VALVE (March 5, 2009)

FDA data resources