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510(k) K111406

BEVER REINFORCED ENDOTRACHEAL TUBE WITH CUFF (ORAL/NASAL), BEVER REINFORCED ENDOTRACHEAL TUBE WITHOUT CUFF (ORAL/NASAL) by Hangzhou Bever Medical Devices Co., Ltd. — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2012
Date Received
May 19, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5730
Review Panel
AN
Submission Type

Other clearances by Hangzhou Bever Medical Devices Co., Ltd.

  • K192468 — Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to (November 27, 2019)
  • K111401 — BEVER ENDOTRACHEAL TUBE, BEVER EVA ENDOTRACHEAL TUBE (July 19, 2012)
  • K111405 — BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP IN (February 13, 2012)

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  • K223130 — Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP ( (August 30, 2023)
  • K211543 — Wei Nasal Jet Tube (July 21, 2022)