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510(k) K221477

AG100s by Hospitech Respiration , Ltd. — Product Code BSK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 2022
Date Received
May 23, 2022
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.

  • K180991 — AG 100s (October 12, 2018)
  • 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)

Other clearances for product code BSK

  • K243562 — CuffGuard (August 12, 2025)
  • K242642 — CuffTrek (March 7, 2025)
  • K220854 — TrachCuff Cuff Controller (April 14, 2023)
  • 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)
  • K180991 — AG 100s (October 12, 2018)
  • K173914 — VORTRAN Cuff Inflator (VCI) (May 25, 2018)
  • K152778 — TRACOE Cuff Pressure Monitor (December 21, 2016)