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510(k) K053466

HSINER RESUSCITATOR by Hsiner Co., Ltd. — Product Code BTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2006
Date Received
December 13, 2005
Clearance Type
Abbreviated
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 Hsiner Co., Ltd.

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  • K091185 — 70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER (July 24, 2009)
  • K082009 — HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS (August 22, 2008)
  • K063268 — CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235 (February 23, 2007)
  • K052811 — HSINER JET NEBULIZER, MODEL HS-31100 (December 21, 2005)

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  • K132172 — NEONATALIE RESUSCITATOR (January 15, 2015)
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