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510(k) K180991

AG 100s by Hospitech Respiration , Ltd. — Product Code BSK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 2018
Date Received
April 16, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cuff, Tracheal Tube, Inflatable
Device Class
Class II
Regulation Number
868.5750
Review Panel
AN
Submission Type

Other clearances by Hospitech Respiration , Ltd.

  • K221477 — AG100s (December 29, 2022)
  • K150157 — AnapnoGuard 100 Respiratory Guard System (February 16, 2016)
  • K131099 — AG MASS (May 13, 2013)
  • K122721 — AG GUFFILL (May 3, 2013)
  • K093126 — ANAPNOGUARD ENDOTRACHEAL TUBE (March 2, 2010)

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  • K221477 — AG100s (December 29, 2022)
  • K202874 — Puritan Bennett Cuff Pressure Manager (January 9, 2021)
  • K192611 — Cuffix (August 13, 2020)
  • K191858 — Pylant Monitor (February 24, 2020)
  • K182548 — Accucuff Cuff Pressure Indicator (January 25, 2019)
  • K173914 — VORTRAN Cuff Inflator (VCI) (May 25, 2018)
  • K152778 — TRACOE Cuff Pressure Monitor (December 21, 2016)