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510(k) K970756

MERCURY MEDICAL REUSABLE CPR BAG by Mercury Medical — Product Code BTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1997
Date Received
March 3, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Manual (Resuscitator)
Device Class
Class II
Regulation Number
868.5915
Review Panel
AN
Submission Type

Other clearances by Mercury Medical

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  • 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)

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  • K181583 — Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resu (December 7, 2018)
  • K170663 — Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremoun (May 11, 2018)
  • K152931 — Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR (August 29, 2016)
  • K132172 — NEONATALIE RESUSCITATOR (January 15, 2015)
  • K112852 — BABI PLUS NEONATAL RESUSCITATION BAG (January 13, 2012)