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510(k) K082092

DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE by Galemed Corp. — Product Code BTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2008
Date Received
July 24, 2008
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 Galemed Corp.

  • K132679 — AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER (April 18, 2014)
  • K133957 — DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE (April 14, 2014)
  • K122627 — GIO DIGITAL PRESSURE GUAGES (August 22, 2013)
  • K072755 — GALEMED CPAP MASK (November 16, 2007)
  • K022124 — GALEMED PEAK FLOW METER, MODELS 3751/3752 (April 3, 2003)
  • K021742 — GALEMED NEB-EASY NEBULIZER (October 25, 2002)

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