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510(k) K142096

T-PIECE RESUSCITATOR by Mercury Medical — Product Code BTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2014
Date Received
August 1, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Powered (Resuscitator)
Device Class
Class II
Regulation Number
868.5925
Review Panel
AN
Submission Type

Other clearances by Mercury Medical

  • K093913 — MERCURY MEDICAL T-PIECE RESUSCITATOR (April 6, 2010)
  • K090710 — MERCURY CPAP (August 20, 2009)
  • 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)

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  • K140049 — MOVES SLC (May 29, 2014)