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510(k) K102120

NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202 by Hsiner Co., Ltd. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2011
Date Received
July 29, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

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  • K063268 — CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235 (February 23, 2007)
  • K053466 — HSINER RESUSCITATOR (March 22, 2006)
  • K052811 — HSINER JET NEBULIZER, MODEL HS-31100 (December 21, 2005)

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