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510(k) K063268

CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235 by Hsiner Co., Ltd. — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2007
Date Received
October 30, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Non-Continuous (Respirator)
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

Other clearances by Hsiner Co., Ltd.

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  • K102120 — NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MOD (August 12, 2011)
  • 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)
  • K053466 — HSINER RESUSCITATOR (March 22, 2006)
  • K052811 — HSINER JET NEBULIZER, MODEL HS-31100 (December 21, 2005)

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