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510(k) K082009

HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS by Hsiner Co., Ltd. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2008
Date Received
July 23, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

Other clearances by Hsiner Co., Ltd.

  • K251888 — VPAP Pediatric Face Mask (March 12, 2026)
  • 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)
  • 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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